Gilead Submits JAK Inhibitor, Filgotinib, Under Priority Review for Rheumatoid Arthritis

The Center for Biosimilars Staff

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

Last month, Gilead Sciences submitted a New Drug Application (NDA) to the FDA for filgotinib under the priority review process. Filgotinib is a Janus kinase (JAK) inhibitor aimed at moderate-to-severe rheumatoid arthritis (RA).

The filing is supported by 52-week data from the global phase 3 FINCH program, Gilead said.

The trials evaluated the efficacy and safety of filgotinib in 3452 patients.

The company said that filgotinib met its primary endpoints and demonstrated durable efficacy and safety results across multiple RA patient populations, including in people with prior inadequate response to methotrexate treatment (MTX), those who were intolerant to 1 or more biologic treatments, and those who were MTX treatment-naïve.

“Safety results were consistent across the trials and further reinforce the long-term safety and tolerability profile of filgotinib for a broad range of RA patients,” said Gilead, which last year invested $5.1 billion in filgotinib’s developer, Belgo-Dutch biotech Galapagos. The 10-year deal gave Gilead the ability to commercialize products for 10 years, and gives the company growth opportunities in inflammatory conditions and arthritis.

Filgotinib is also being studied in ulcerative colitis and Crohn disease.

“The new drug application submission for filgotinib represents an important step forward in bringing a potential new treatment option to people living with RA,” said Merdad Parsey, MD, PhD, Gilead’s chief medical officer, in a statement. “In clinical trials, filgotinib has demonstrated an efficacy and tolerability profile that may offer meaningful improvements in RA treatment response for patients with this chronic, debilitating disease.”

This filing is the third regulatory agency submission for filgotinib in the past 5 months; it has also been submitted with the European Medicines Agency and the Japanese Ministry of Health, Labor and Welfare.