FDA Action Alert: Evofem, Sanofi, Regeneron and Incyte

 

Heading into the first week after Memorial Day, which in the U.S. marks the typical beginning of summer, the U.S. Food and Drug Administration (FDA) has a number of drug approvals on the calendar. Here’s a look.

Evofem’s Phexxi for Prevention of Pregnancy

Evofem Biosciences had a target action date of May 25 for its resubmission of a New Drug Application (NDA) for Phexxi, a Multipurpose Vaginal pH Regulator (MVP-R) for the prevention of pregnancy. The resubmission includes full data from the Phase III AMPOWER trial, a confirmatory single-arm, open-label Phase III study of the efficacy and safety of the drug in about 1,400 healthy women ages 18 to 35 years. The FDA approved the drug on May 22.

At the company’s first-quarter report on May 6, the company indicated that because of the COVID-19 pandemic, they have decided to push the planned commercial launch of Phexxi back to the first week of September.

Saundra Pelletier, Evofem’s chief executive officer, said at the time, “We are now less than three weeks away from the PDUFA data for Phexxi and the potential to deliver the first non-hormonal contraceptive innovation in decades. We are encouraged by our ongoing discussions with the FDA regarding the potential label for Phexxi and we look forward to sharing more details about our unique Phexxi TeleContraception platform and other launch initiatives.”

Sanofi and Regeneron’s Dupixent for Kids with Atopic Dermatitis

Regeneron Pharmaceuticals and Sanofi have a target action date of May 26 for their supplemental Biologics License Application (sBLA) for Dupixent (dupilumab) as an add-on maintenance treatment for children aged 6 to 11 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription drugs or when those therapies are not recommended. The sBLA is built on data that includes a pivotal Phase III trial in children with severe dermatitis.

Dupixent is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) proteins. It is approved in the U.S. for patients 12 years and older with moderate-to-severe dermatitis that is not well controlled with prescription drugs used on the skin or who can’t use topical therapies. It is also approved for use with other asthma medicines for the maintenance of moderate-to-severe eosinophilic or oral steroid dependent asthma in people aged 12 years or older whose asthma is not well controlled, and for use with other drugs to treat CRSwNP in adults whose disease is not controlled.

Incyte’s Pemigatinib for Metastatic Cholangiocarcinoma

Incyte had a target action date of May 30 for its NDA for pemigatinib, a selective fibroblast growth factor receptor (FGFR) inhibitor for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. Cholangiocarcinoma is a rare bile duct cancer. The agency approved the drug for this indication on April 17, which will be marketed under the brand name of Pemazyre.

The drug was under Priority Review. The NDA was based on data from the FIGHT-202 trial. Pemigatinib monotherapy demonstrated an overall response rate (ORR) of 36%, the primary endpoint, and median duration of response (DOR) of 7.5 months (secondary endpoint) with a median follow-up of 15 months.

“There is a significant need for new therapies for patients with cholangiocarcinoma, who have limited treatment options beyond first-line chemotherapy and often face a poor prognosis,” said Peter Langmuir, group vice president, Targeted Therapeutics, in Incyte, in a November 2019 announcement. “We are very pleased that the FDA has accepted our NDA for Priority Review which we believe represents an important step toward providing the first treatment option for patients with previously treated, locally advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements. We intend to work closely with the FDA to bring this innovative targeted therapy to patients suffering from this devastating disease as soon as possible.”

FGFRs play a significant role in tumor cell proliferation and survival, migration and angiogenesis. In addition to the Priority Review, the FDA granted the drug Breakthrough Therapy designation and Orphan Drug designation for cholangiocarcinoma.