Pfizer announced in a statement that the prespecified non-inferiority criteria for a post-marketing safety study of the rheumatoid arthritis drug Xeljanz (tofacitinib) were not met, but the company remains hopeful that future analyses of the study will be more promising.
As concerns over the price of prescription medicine continue to make headlines as the country barrels toward another election, a new study from the Scripps Research bolsters an argument touted by the pharmaceutical industry over the rebate system.
High Dose of Pfizer’s Xeljanz Raises Red Flag in a Post-Marketing Study
Ankylosing Spondylitis (AS), Blockbusters, Drug Safety Concerns, FDA, FDA/Regulatory, Janus Kinase (JAK) Inhibitors, Juvenile Idiopathic Arthritis, Postmarket Studies, Priority Review, Psoriatic Arthritis, Rheumatoid Arthritis, Therapeutics, Tumor Necrosis Factor (TNF) InhibitorsPfizer’s blockbuster rheumatoid arthritis drug Xeljanz has been a strong performer for the company, bringing in $1.77 billion in revenue last year, but now the company has indicated it intends to make a change in a post-marketing study due to safety concerns.
Top 200 Medicines Annual Report 2018: Blockbusters thriving despite tumultuous climate
Analysts, Analytics, Approvals, August 2018, Biologics, Biosimilars, Blockbusters, Business, Cannabinoids, Dravet syndrome, Epilepsy, EvaluatePharma, FDA/Regulatory, Gastroenterology, GlobalData, Immunological Disorders, Immunology, Immunomodulator Drugs, Innovation, Issue Archives, Lennox-Gastaut Syndrome (LGS), Mantle Cell Lymphoma (MCL), Myelodysplastic Syndromes, Prostate Cancer, Shingles, Special Reports, Therapeutics, Top 200 Medicines, Tumor Necrosis Factor (TNF) Inhibitors, Ulcerative ColitisThere were as many billion-dollar brands in 2017 as there have been in any other calendar year despite the cratering effects of massive patent cliffs in 2012 and 2015.
Eli Lilly announced the results of the company’s COAST-W Phase III clinical trial of Taltz (ixekizumab) to treat ankylosing spondylitis. The study met both primary and major secondary endpoints.
Amgen announced results from a Phase 3 study evaluating the efficacy and safety of biosimilar candidate ABP 710 compared with Remicade (infliximab) in patients with moderate-to-severe rheumatoid arthritis.
AbbVie announced today a global resolution of all intellectual property-related litigation with Amgen over Amgen’s proposed biosimilar adalimumab product.
A biosimilar version of AbbVie Inc.’s blockbuster arthritis drug Humira, produced by a joint venture of Biogen Inc. and Samsung Biologics, was approved by EU regulators.
2017 Annual Report – Top 200 Medicines: Humira Remains Atop The Throne
Analysts, August 2017, Autoimmune Diseases, Autoimmune Disorders, Biologics, Biosimilars, Blockbusters, Blood Cancers, Breast Cancer, Cervical Cancer, Colorectal Cancer, Forecasts, Forecasts, Gastroenterology, Hepatitis C, Immunology, Inflammatory Diseases, Japan, Kidney Cancer, Mantle Cell Lymphoma (MCL), Multiple Myeloma, Ovarian Cancer, Pneumococcal Disease, Pneumonia, Relapsed Glioblastoma, Rheumatoid Arthritis, Rheumatology, Special Reports, Therapeutics, Top 200 Medicines, Tumor Necrosis Factor (TNF) Inhibitors, Ulcerative Colitis, Vaccines, VasculitisAbbVie’s biologic therapy Humira for autoimmune disorders continues to dominate the sales landscape; Gilead’s once-daily hepatitis C treatment Harvoni in 2016 repeated its performance as the world’s second-best-selling prescription medicine.
EULAR 2017: Lilly’s Taltz (ixekizumab) Demonstrated Significant Improvements in Disease Signs and Symptoms at 24 Weeks Among Patients with Active Psoriatic Arthritis Who Had Prior Inadequate Response or Intolerance to TNF Inhibitors
Active Psoriatic Arthritis (PsA), Tumor Necrosis Factor (TNF) InhibitorsEli Lilly and Company announced that patients with active psoriatic arthritis who had inadequate response to one or two TNF inhibitors or were intolerant of TNF inhibitors treated with Taltz (ixekizumab) achieved significant improvement in signs and symptoms of their disease at 24 weeks when compared to placebo.