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Pfizer 2019: Success and a successor

Written by: | chris.truelove@medadnews.com | Dated: Monday, October 14th, 2019

 

After a 2018 in which Pfizer reorganized the company’s businesses and built on a foundation for future growth, 2019 features a new executive chairman, the completion of a consumer health joint venture, the prospect of merging its legacy medicines company with Mylan and an $11.4 billion biotech acquisition.

 

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Pfizer Inc.

235 East 42nd Street
New York, NY 10017
Phone: 212-733-2323
Website: pfizer.com

 

Best-Selling Products

Product 2018 Sales 2017 Sales
Prevnar, Prevenar 13 $5,802 $5,601
Lyrica $4,970 $5,065
Ibrance      $4,118 $3,126
Eliquis* $3,434 $2,523
Enbrel $2,112 $2,452
Lipitor $2,062 $1,915
Xeljanz $1,774 $1,345
Chantix/Champix $1,085 $997
Sutent $1,049 $1,081
Norvasc $1,024 $926
Premarin family $832 $977
Xtandi* $699 $590
Celebrex $686 $775
Inflectra/Remsima $642 $419
Viagra $636 $1,204
Sulperazon $613 $471
Genotropin $558 $532
BeneFix $554 $604
Xalkori $524 $594
Refacto AF, Xyntha $514 $551

All sales are in millions of dollars.

* Eliquis and Xtandi figures include alliance revenue

 

Financial Performance

  2018 2017
Revenue $53,647 $52,546
Net income $11,153 $21,308
Diluted EPS $1.87 $3.52
R&D expense $8,006 $7,683
  1H 2019 1H 2018
Revenue $26,382 $26,373
Net income $8,929 $7,432
Diluted EPS $1.56 $1.24
R&D expense $3,544 $3,540

All figures are in millions of dollars, except EPS.

 

Outcomes Creativity Index Score: 30
Manny Awards – 4
Cannes Lions – 4
LIA: Health & Wellness – N/A
Clio Health – N/A
One Show: HW&P – 1
MM&M Awards – 20
Global Awards – 1
Creative Floor Awards – N/A

 

Pfizer is continuing to squarely face the future as the company begins to see the results of plans laid in 2018 and earlier to take the company past the patent expiration of several top-selling drugs, including Lyrica. And in 2019, Pfizer designated a new executive chairman, completed its consumer health joint venture with GlaxoSmithKline, announced the proposed merger of its Upjohn division with Mylan and announced the acquisition of the biotech company Array.

In 2018, the company had taken several actions to prepare Pfizer to capitalize on future opportunities that executives believe will create significant opportunities for Pfizer to grow in the years ahead.

“We are creating a new champion for global health … By bringing Mylan’s growth assets to Upjohn’s growth markets, we will create a financially strong company with true global reach,” says CEO Alfred Bourla, DVM, Ph.D.

These opportunities are macro trends such as an aging population and a rising middle class in emerging markets that will result in an increased number of people seeking access to both innovative and established medicines; the potential to launch up to three to five new products or product line extensions per year over the next five years; and a “dramatic abatement” in products losing exclusivity until the second half of the next decade, after Lyrica loses marketing exclusivity.

During July 2018, Pfizer announced that a reorganization into three businesses to better capitalize on the evolving and unique dynamics of individual markets. The three businesses, which became effective at the beginning of the company’s 2019 fiscal year, are Pfizer Biopharmaceuticals Group, a science-based innovative medicines business that now includes biosimilars and a new Hospital business unit for anti-infectives and sterile injectables; Upjohn, an off-patent branded and generic medicines business based in China that is bringing 20 of the company’s most iconic brands to more than 100 markets around the world; and a Consumer Healthcare business aligned with the growing trend of consumers taking their health into their own hands.

According to executives, by bringing the biosimilars into their therapeutic categories, Pfizer can potentially leverage its R&D, regulatory, and commercial infrastructures within the company’s Biopharma business to more efficiently bring these products to market. By making a business solely focused on medicines that are used in hospitals, Pfizer can bring greater focus to serving those customers and developing those relationships.

To further unlock value for shareholders, and to allow the company to sharpen its focus on the pharmaceuticals business, Pfizer signed an agreement with GlaxoSmithKline (see profile on page 44) in December 2018 to form a Consumer Healthcare joint venture. The transaction was completed in August 2019, and combines GSK’s Sensodyne, Voltaren and Panadol and Pfizer’s Advil, Centrum and Caltrate. Executives say the joint venture is the global leader in OTC products and has number one or two market share positions in all key geographies, including the United States and China.

“The successful closing of the joint venture represents an important and exciting step in forming a world-class pure-play consumer healthcare business,” says Pfizer CEO Alfred Bourla, DVM, Ph.D. “It also furthers Pfizer’s evolution to be a more focused, global leader in science-based, innovative medicines that delivers breakthroughs that change patients’ lives and creates long-term value for shareholders.”

As part of the agreement, three out of the nine members of the joint venture’s board have been appointed by Pfizer and include John Young, group president, chief business officer; Douglas Giordano, senior VP, Worldwide Business Development and Bryan Supran, senior VP, deputy general counsel. Executives say the transaction is expected to deliver $650 million in peak cost synergies and to be slightly accretive on a full-year basis for Pfizer in each of the first three years following the closing.

GSK intends to separate the joint venture as an independent company via a demerger of its equity interest to its shareholders and a listing of the joint venture on the UK equity market. GSK will have the sole right to decide whether and when to initiate a separation and listing for a period of five years following the closing. GSK may also sell all or part of its stake in the joint venture in a contemporaneous IPO. Should a separation and listing occur during the first five years after closing, Pfizer has the option to participate through the distribution of its equity interest in the joint venture to its shareholders or the sale of its equity interest in a contemporaneous IPO. After the fifth anniversary of the closing, both GSK and Pfizer will have the right to decide whether and when to initiate a separation and public listing of the joint venture.

Less than eight months after Pfizer reorganized its businesses, more reorganization is on the horizon. In July 2019, the company announced that the recently formed Upjohn division was merging with Mylan Pharmaceuticals Inc. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57 percent of the combined new company, and Mylan shareholders would own 43 percent.

Executives expect the new company will transform and accelerate each businesses’ ability to serve patients’ needs and expand their capabilities across more than 165 markets. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, such as central nervous system and anesthesia, infectious disease and cardiovascular, as well as a robust pipeline, high-quality manufacturing, and supply chain excellence. Upjohn brings trusted, iconic brands, such as Lipitor (atorvastatin calcium), Celebrex (celecoxib) and Viagra (sildenafil), and proven commercialization capabilities, including leadership positions in China and other emerging markets.

According to management, the transaction will allow the new company to meaningfully expand the geographic reach of Mylan’s existing portfolio and future pipeline – including significant investments that have been made across complex generics and biosimilars – into new growth markets where Upjohn has existing sales infrastructure and local market expertise.

The new company, which will be renamed and rebranded at close, will be led by Mylan Chairman Robert J. Coury, who will serve as executive chairman of the new company; Michael Goettler, current group president, Upjohn, who will serve as CEO; and Rajiv Malik, currently Mylan’s president, who will serve as president. Ken Parks, currently chief financial officer of Mylan, has agreed to depart the company at closing. Heather Bresch, Mylan’s current CEO, will retire from Mylan upon the close of this transaction.

The new company will be domiciled in the United States and incorporated in Delaware, operating global centers in Pittsburgh, Pa., Shanghai, China, and Hyderabad, India.

“We are creating a new champion for global health – one poised to bring world-class medicines to patients across a wide range of therapeutic areas,” Dr. Bourla says. “For Pfizer, this transaction represents our sharpened focus on innovative medicines and is a testament to our purpose – breakthroughs that change patients’ lives. At the same time, we’ll maintain the financial flexibility to advance our strong pipeline, invest for growth and continue to return capital to our shareholders.”

Pfizer also announced significant acquisitions in 2019. The company successfully completed the acquisition of the privately held clinical stage biotechnology company, Therachon. Under the terms of the transaction, Pfizer acquired Therachon for $340 million with another $470 million in additional payments contingent on the achievement of key milestones in the development and commercialization of TA-46, an investigational medicine. The drug is being developed for the treatment of achondroplasia, a genetic condition and the most common form of short-limb dwarfism.

In June 2019, Pfizer announced a definitive merger agreement to acquire Array, a commercial stage biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule medicines to treat cancer and other diseases of high unmet need. Pfizer agreed to acquire Array for $48 per share in cash, for a total enterprise value of approximately $11.4 billion.

Array’s portfolio includes the approved combined use of Braftovi (encorafenib) and Mektovi (binimetinib) for the treatment of BRAFV600E or BRAFV600K mutant unresectable or metastatic melanoma. The combination therapy has significant potential for long-term growth via expansion into additional areas of unmet need and is being investigated in over 30 clinical trials across several solid tumor indications, including the Phase III BEACON trial in BRAF-mutant metastatic CRC.

Upon the close of the transaction, which occurred at the end of July, Array’s employees joined Pfizer and continue to be located in Cambridge, Mass., and Morrisville, N.C., as well as in Boulder, Colo., which became part of Pfizer’s Oncology R&D network in addition to La Jolla, Calif., and Pearl River, N.Y.

Pfizer executives say the majority of the transaction will be financed with debt and the balance with existing cash. The transaction is expected to be dilutive to Pfizer’s adjusted diluted earnings per share by about 4 cents in 2019, dilutive by 4 cents to 5 cents in 2020, neutral in 2021, and accretive beginning in 2022, with additional accretion and growth anticipated thereafter.

And for Pfizer, the changes in 2019 keep coming. In September, the company’s board announced that Executive Chairman Ian C. Read will be retiring in December, and tapped Bourla as his successor.

Read, who joined Pfizer in 1978, was named CEO of Pfizer in 2010 and chairman of the board of directors in 2011.

“It’s been my greatest privilege to serve alongside Pfizer colleagues for the past 41 years,” Read says. “Their compassion, integrity, intellectual rigor and commitment to patients are what make Pfizer such an extraordinary company, and I’m proud to have been part of its history.

“I have tremendous confidence in Albert, the board, and our colleagues, and believe that Pfizer’s best days are yet to come – which is an exciting thought for patients and their families across the globe.”

According to Shantanu Narayen, lead independent director for Pfizer’s board, Bourla brings a unique set of skills to the position, observed during his tenure as CEO and while serving as chief operating officer and the leader of several global businesses. “All of this makes him the logical choice to take on the role of chairman at this important point in Pfizer’s history,” Narayen says. “We are confident that Albert, with his unwavering passion for patients, will do an excellent job leading our board, while continuing to advise management and shepherd the business.”

Financial and Product Performance

Pfizer generated revenue of $53.65 billion in 2018, 2.1 percent more than in 2017. The majority of Pfizer’s 2018 revenue – 47 percent – came from the United States, with 8 percent from Japan, 8 percent from China, and 37 percent from the rest of the world.

Direct sales and alliance revenue for the blood thinner Eliquis increased to $3.43 billion for 2018.

Net income was $11.15 billion compared with $21.31 billion in 2017, and diluted earnings per share were $1.87 compared with $3.52.

For the first half of 2019, revenue was $26.38 billion, about the same as in the corresponding period last year. Net income totaled $8.93 billion, 20 percent more than in first-half 2018. Diluted earnings were share for the first half were $1.56, 25.8 percent more than in first-half 2017.

The company’s biggest-selling medicines and vaccines continued to grow, including Ibrance, Eliquis, Xeljanz and Prevnar 13/Prevenar 13. Pfizer executives say the growth in these areas helped to absorb $1.7 billion in lost revenue because of products that recently lost marketing exclusivity.

Pfizer’s top-selling product in 2018 was Prevnar 13/Prevenar 13. Sales for the vaccine came in at $5.8 billion, 3.6 percent more than in 2017. In first-half 2019, Prevnar sales were $2.67 billion, 1.3 percent more than in the first half of 2018.

Second was Lyrica, which posted sales of $4.97 billion, almost 2 percent less than in 2017. Sales in the first half of 2019 were $2.36 billion, 3 percent less than in the same period of the previous year.

Sales of the oncology drug Ibrance grew to $4.12 billion in 2018.

At No. 3 in 2018 was the oncology drug Ibrance, generating $4.12 billion, 31.7 percent more than in 2017. In the first six months of 2019, Ibrance sales were $2.39 billion, 22 percent more than in first-half 2018.

Next in line was the blood thinner Eliquis, which generated direct sales and alliance revenue of $3.43 billion, with 36 percent growth from 2017. During first-half 2019 the drug accounted for $2.1 billion, 26.7 percent more than in first-half 2018.

The rheumatoid arthritis drug Enbrel was the fifth-best selling product for Pfizer in 2018, with sales of $2.11 billion, 13.9 percent less than in 2017. In the first half of 2019, sales were $871 million, a decline of 17.6 percent compared with first-half 2018.

At No. 6 in 2018 sales was the cholesterol drug Lipitor, generating $2.06 billion, 7.7 percent more than in 2017. Sales for first-half 2019 were $1.08 billion, about the same as in the first six months of last year.

Pfizer’s seventh best-seller was the rheumatoid arthritis, psoriatic arthritis and ulcerative colitis drug Xeljanz, which made $1.77 billion in 2018, 32 percent more than in 2017. First-half 2019 sales were $1.04 billion, 31.5 percent more than in first-half 2018.

Coming in at No. 8 was the smoking cessation drug Chantix/Champix, with $1.09 million, an increase of 8.8 percent from 2017. Sales in the first half of 2019 were $549 million, 4 percent less than in first-half 2018.

The oncology drug Sutent placed No. 9 in sales, with $1.05 billion, 3 percent less than in 2017. During the first half of 2019, Sutent sales declined 11 percent from first-half 2018 to $480 million.

At No. 10 was the hypertension drug Norvasc, with sales of $1.02 billion, 10.6 percent more than in 2017. In the first half of 2019, sales were $516 million, 2.5 percent than in the same period last year.

The Premarin family of hormone replacement products was the 11th best seller in 2018 at $832 million, a decline of 14.8 percent. Sales in the first six months of 2019 were $361 million, 10 percent less than in same period of 2018.

The oncology drug Xtandi accounted for $699 million in alliance revenue during 2018, growing 18.5 percent from 2017. The first-half 2019 total was $369 million, 11.8 percent more than in first-half 2018.

Sales for the anti-inflammatory drug Celebrex during 2018 came in at $686 million, down 11.5 percent from the previous year. First-half 2019 sales were $347 million, 13.4 percent more than in first-half 2018.

2018 sales for the immunosuppressive drug Inflectra/Remsima were reported at $642 million, compared with $419 million in 2017. Sales in the first six months of 2019 were $291 million, down 4 percent from the first half of 2018.

The erectile dysfunction drug Viagra produced sales of $636 million last year compared with 2017’s $1.2 billion figure. In the first half of 2019, sales were $259 million, 30 percent less than in first-half 2018.

The combination antibiotic Sulperazon, which is used in the hospital setting, produced sales of $613 million in 2018. The product generated $613 million compared with $471 million in 2018. First-half 2019 sales were $342 million, 7 percent more than in the same period last year.

R&D and the pipeline

The first half of 2019 marked many advances for Pfizer’s pipeline, including approvals.

In May, Pfizer and Merck KGaA announced that the U.S. Food and Drug Administration approved Merck’s Bavencio in combination with Pfizer’s Inlyta for the first-line treatment of patients with advanced renal cell carcinoma.

Pfizer announced during May that the European Commission granted conditional marketing authorization for Lorviqua – known in the United States, Canada and Japan as Lorbrena – as a monotherapy for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive advanced non-small cell lung cancer (NSCLC) whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or crizotinib and at least one other ALK TKI.

In July, Pfizer announced that the FDA approved Ruxience, a biosimilar to Rituxan, for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, and granulomatosis with polyangiitis and microscopic polyangiitis.

In June, Pfizer announced that the FDA approved Zirabev, a biosimilar to Avastin, for the treatment of five types of cancer: metastatic colorectal cancer (CRC); unresectable, locally advanced, recurrent or metastatic NSCLC; recurrent glioblastoma; metastatic RCC; and persistent, recurrent or metastatic cervical cancer.

FDA during August accepted for review, from Pfizer and partner Astellas, the filing of a supplemental New Drug Application for Xtandi (enzalutamide) to add an indication for the treatment of men with metastatic hormone-sensitive prostate cancer (mHSPC). The application has also been granted Priority Review. Xtandi is currently indicated in the United

States for the treatment of patients with castration-resistant prostate cancer (CRPC). The FDA had set a target action date in fourth-quarter 2019.

“The submission is supported by a strong data package, including two Phase III trials investigating Xtandi in men living with this form of prostate cancer,” says Chris Boshoff, M.D., Ph.D., chief development officer, Oncology.

Pfizer announced in June that the EC approved Talzenna as monotherapy for the treatment of adult patients with germline breast cancer susceptibility gene 1/2-mutations, who have human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer. This approval follows the medicine’s approval by the FDA in October 2018.

Also in May, Pfizer announced that the FDA approved both Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) for the treatment of cardiomyopathy of wild-type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization. Vyndaqel and Vyndamax are two oral formulations of the first-in-class transthyretin stabilizer tafamidis, and the first medicines approved by the FDA to treat ATTR-CM.

In the clinical trial area, July brought the news of topline results from a Phase IV study, CrisADe CARE 1. Eucrisa (crisaborole) showed that crisaborole ointment, 2%, was well-tolerated in children aged 3 months to less than 24 months with mild-to-moderate atopic dermatitis. Crisaborole ointment, 2%, is approved in select countries for mild-to-moderate atopic dermatitis in patients 2 years of age and older.

In June, Pfizer announced positive results from ORAL Shift, a Phase IIIb/IV study in adult patients with moderately to severely active rheumatoid arthritis. Patients who achieved low disease activity with Xeljanz extended release 11 mg once daily (Xeljanz XR) plus methotrexate (MTX) after a 24-week open-label run-in period, were randomized to evaluate the efficacy and safety of Xeljanz XR as monotherapy after MTX withdrawal compared with Xeljanz XR with continued MTX. The study demonstrated non-inferiority of MTX withdrawal with Xeljanz XR compared to Xeljanz XR plus. The study results were presented during a late-breaking oral session at the Annual European Congress of Rheumatology.

Pfizer announced positive top-line results during May from a Phase III pivotal study, JADE MONO-1, evaluating the efficacy and safety of its investigational oral Janus kinase 1 (JAK1) inhibitor, abrocitinib, in patients aged 12 and older with moderate to severe AD. JADE MONO-1 was a randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy and safety of two doses (100 mg and 200 mg once daily) of abrocitinib monotherapy over 12 weeks. Top-line results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and each key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo. In addition, the results demonstrate response to treatment for a statistically significant number of patients during the first two to four weeks following first dose.

Pfizer announced during September positive top-line results from a second Phase III pivotal study of abrocitinib in patients aged 12 and older with moderate to severe atopic dermatitis (AD). This is the second monotherapy trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program (B7451013, or JADE MONO-2). Consistent with JADE MONO-1, results showed that by week 12 the percentage of patients achieving each co-primary efficacy endpoint and key secondary endpoint with either dose of abrocitinib was statistically significantly higher than placebo.

In addition, a statistically significant number of patients achieved a reduction in pruritus by week two, as measured by a four-point or larger reduction in itch severity measured with the pruritus numerical rating scale (NRS).

In June at the 25th Annual Parent Project Muscular Dystrophy Connect Conference, Pfizer presented initial Phase Ib clinical data for PF-06939926, an investigational gene therapy to potentially treat Duchenne muscular dystrophy (DMD). The primary endpoint of the ongoing study is to assess the safety and tolerability of this investigational gene therapy.

Secondary endpoints of the clinical study include measurement of expression of mini-dystrophin distribution within muscle fibers by immunofluorescence and concentration by liquid chromatography mass spectrometry.

Pfizer aims to enroll approximately 12 boys with DMD who are ambulatory and aged 5 to 12. At least six study participants ranging in age from 6 to 12 years have received the one-time intravenous dose of PF-06939926 at either 1e14 vector genomes/kilogram (vg/kg) or 3e14 vg/kg, as quantified using an inverted terminal repeat-based quantitative polymerase chain reaction (qPCR) drug product titer assay.

As Pfizer continues to collect data from this study, the company is also in the planning stages for a global, randomized, placebo-controlled Phase III study. This study is expected to begin in the first half of 2020 with commercial-scale manufacturing processes using multiple 2000-liter bioreactors. The anticipated Phase III study intends to leverage the learnings from the ongoing Phase Ib study in order to inform Pfizer’s decisions regarding the optimal dose, assay, method of administration, concomitant medications, participant selection, and safety monitoring.

On the vaccines front, Pfizer in September announced positive preliminary results following administration of three doses in a four-dose series for a proof-of-concept Phase II study (B7471003) to assess safety and immunogenicity of its 20-valent pneumococcal conjugate vaccine (20vPnC) candidate, PF-06482077, being investigated for the prevention of invasive disease and otitis media caused by Streptococcus pneumoniae serotypes contained in the vaccine in healthy infants.

“20vPNC induced immune responses for all 20 serotypes in infants,” says Kathrin U. Jansen, Ph.D., senior VP and head of Vaccine R&D, Pfizer. “These findings are encouraging and should support the program’s advancement to Phase III. Once data with the fourth dose are available, we will discuss Phase III plans with regulators.

The pneumoccocal vaccine Prevnar 13/Prevenar 13 became Pfizer’s best-selling product in 2018, at $5.8 billion.

Pfizer’s 20vPnC candidate includes the 13 serotypes contained in Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) plus seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F, and 33F).

Not all the regulatory and development news was positive. In August, Pfizer announced that the Phase III pivotal study for rivipansel (GMI-1070), RESET, did not meet its primary or key secondary efficacy endpoints. The objective of the trial was to evaluate the efficacy and safety of rivipansel in patients aged 6 and older with sickle cell disease (SCD) who were hospitalized for a vaso-occlusive crisis (VOC) and required treatment with intravenous (IV) opioids. The primary endpoint was time to readiness-for-discharge and the key secondary efficacy endpoints were time-to-discharge, cumulative IV opioid consumption, and time to discontinuation of IV opioids.

“We are disappointed with the results, as we have been working in close partnership with the SCD community to advance rivipansel as a potential treatment option for acute VOC,” says Brenda Cooperstone, M.D., senior VP and chief development officer, Rare Disease, Pfizer Global Product Development. “We plan to share the study data at an upcoming scientific meeting as we want to ensure the learnings from this trial help inform future sickle cell programs that aim to improve care for SCD patients experiencing a VOC.”

Pfizer in June reported that a Phase III study to assess the efficacy and safety of intravenous (IV) sildenafil when added to inhaled nitric oxide (iNO) for the treatment of newborns with persistent pulmonary hypertension (PPHN) did not meet its primary efficacy endpoint. Treatment with IV sildenafil when added to iNO did not result in a statistically significant reduction in treatment failure rate or time on iNO compared to treatment with iNO alone. The study was part of an EU Pediatric Investigational Plan (PIP).

In July, the FDA updated the U.S. prescribing information for Xeljanz to include two additional boxed warnings as well as changes to the indication and dosing for ulcerative colitis. These updates were based on the FDA’s review of data from the post-marketing requirement RA study A3921133.

In May, Pfizer announced that the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) issued recommendations limiting the use of Xeljanz 10 mg twice daily (BID) in patients at increased risk of pulmonary embolism (PE) in the European Union. These recommendations have been incorporated in updated EU product labeling for Xeljanz, which Pfizer executives say is provisional, while PRAC undertakes a review of all available evidence on the safety and efficacy of the drug.

The review is a result of the observation of increased risk of PE with tofacitinib 10 mg BID in an ongoing FDA post-marketing requirement study in individuals with RA who had one or more underlying cardiovascular risk factors. Specifically, it is recommended that tofacitinib 10 mg BID should not be prescribed to patients who are at high risk of PE. Additionally, patients who are already taking 10 mg BID and are at high risk of PE should be switched to alternative treatments.

In the EU, tofacitinib 10 mg BID is an approved dose for UC patients but is not an approved dose for patients with moderate-to-severe RA nor for those with active psoriatic arthritis.

The review is being carried out by PRAC, the committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations at the request of the EC. The PRAC recommendations will then be forwarded to the Committee for Medicinal Products for Human Use. The final stage of the review procedure is the adoption by the EC of a legally binding decision applicable in all EU Member States.

In June, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) voted to revise the pneumococcal vaccination guidelines and recommend Prevnar 13, based on shared clinical decision making, for adults 65 years or older who do not have an immunocompromising condition and who have not previously received Prevnar 13. This represents a change from the current CDC recommendation for routine use among all immunocompetent adults aged 65 years and older. This new recommendation means the decision to vaccinate should be made at the individual level between health care providers and their patients.

Once the ACIP recommendation has been reviewed and approved by the CDC Director and the U.S. Department of Health and Human Services, it would be published in CDC’s Morbidity and Mortality Weekly Report. Prevnar 13 continues to be routinely recommended for adults with immunocompromising conditions.

 

 

 

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