Gilead Submits NDA to FDA for Filgotinib as a Treatment for Moderate-to-Severe Rheumatoid Arthritis

Today, Gilead Sciences announced that it has submitted a New Drug Application (NDA) to the U.S. FDA for filgotinib, a JAK1 inhibitor, for the treatment of adult patients with moderate-to-severe rheumatoid arthritis. Filgotinib is one of Gilead Sciences’ key development programs in the field of inflammatory diseases. Concurrently with the NDA submission, the company utilized a Priority Review Voucher to shorten the FDA’s review timeline, demonstrating Gilead Sciences’ commitment to bringing this innovative therapy to market as soon as possible.

Rheumatoid arthritis (RA) is a chronic inflammatory disease that can impair function in multiple joints. As an autoimmune disorder, it arises when the immune system attacks the synovium within the joints, leading to inflammation and synovial thickening, which ultimately damages the cartilage and bone. RA affects 23.7 million people worldwide. Methotrexate (MTX) is typically the first-line therapy for this condition; however, many patients are intolerant to or exhibit a poor response to MTX, necessitating new therapeutic approaches to mitigate disease progression.

Filgotinib is a selective JAK1 inhibitor jointly developed by Gilead Sciences and Galapagos. JAK kinase-dependent cytokines are associated with the pathogenesis of many inflammatory and autoimmune diseases. This characteristic suggests that JAK inhibitors can be used to treat various inflammatory diseases, including rheumatoid arthritis.

This application is supported by data obtained from the global Phase 3 clinical development program named FINCH. For example, in the randomized, double-blind, placebo- and active-controlled FINCH 1 trial, patients who had previously received methotrexate (MTX) but had an inadequate response were treated with filgotinib, placebo, or adalimumab. All patients continued to receive MTX concurrently. The trial results demonstrated that after 12 weeks, the proportion of patients treated with filgotinib who achieved ACR20 (one of the American College of Rheumatology response criteria) was significantly higher than that in the placebo group, thereby meeting the primary endpoint of the trial.

▲Overview of Efficacy Data from the FINCH 1 Clinical Trial (Image source: Reference [2])

In the FINCH 3 clinical trial, filgotinib was evaluated as monotherapy or in combination with methotrexate (MTX) for the treatment of MTX-naïve patients with rheumatoid arthritis (RA). The results demonstrated that after 24 weeks of treatment, the combination therapy of filgotinib and MTX significantly increased the proportion of patients achieving an ACR20 response compared with MTX alone. The combination therapy also met multiple key secondary endpoints.

▲Overview of Efficacy Data from the FINCH 3 Clinical Trial (Image source: Reference [2])

“This new drug application represents an important step in the process of bringing this innovative treatment option to patients with rheumatoid arthritis,” said Dr. Merdad Parsey, Chief Medical Officer of Gilead Sciences, Inc. “In clinical trials, filgotinib demonstrated favorable efficacy and tolerability, providing meaningful improvements for patients with rheumatoid arthritis.”

References:

[1] Gilead Submits Filgotinib New Drug Application to U.S. Food and Drug Administration Under Priority Review for Rheumatoid Arthritis Treatment. Retrieved December 19, 2019, from https://www.businesswire.com/news/home/20191219005768/en

[2] Gilead and Galapagos Announce Filgotinib Meets Primary and Key Secondary Endpoints in the Phase 3 FINCH 1 Rheumatoid Arthritis Study. Retrieved March 29, 2019, from https://www.businesswire.com/news/home/20190328005952/en/

Original Title: Express | Gilead Submits New Drug Application for JAK1 Inhibitor Using Priority Review Voucher for the Treatment of Rheumatoid Arthritis

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