Gilead and Galapagos Announce EMA Validation of Marketing Authorization Application for Filgotinib in Rheumatoid Arthritis

Compiled by: Fan Dongdong

Recently, Gilead Sciences and Galapagos jointly announced that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for filgotinib, an oral selective JAK1 inhibitor, for the treatment of rheumatoid arthritis in adults. The agency is currently evaluating the drug.

This application is based on the results of the Phase 3 clinical trial FINCH 3, a randomized, double-blind, active-controlled, 52-week Phase 3 study that enrolled 1,252 adult patients with moderately to severely active rheumatoid arthritis (RA) who were naïve to methotrexate (MTX) treatment (i.e., MTX-naïve), and evaluated the efficacy and safety of filgotinib as monotherapy and in combination with MTX.

In March this year, Gilead and Galapagos announced the 24-week trial data from the Phase III clinical study of filgotinib for the treatment of rheumatoid arthritis. The results showed that the combination therapy of filgotinib + MTX demonstrated significant efficacy in patients who had not previously received methotrexate (MTX) treatment.

The study met its primary endpoint. At Week 24, the proportions of patients achieving ACR20 response were significantly higher in the filgotinib 100 mg/200 mg plus methotrexate (MTX) groups compared with the MTX monotherapy group. The proportions of patients achieving ACR50, ACR70, and clinical remission were also significantly higher. Furthermore, at Week 24, patients treated with filgotinib demonstrated greater improvements in Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Filgotinib 200 mg monotherapy inhibited the progression of structural damage, as assessed by the modified Total Sharp Score (mTSS). Regarding safety, the findings were consistent with the 24-week safety results from previous studies.

In December 2015, Gilead Sciences entered into an agreement with Galapagos worth up to $2 billion to co-develop filgotinib, a highly selective JAK1 inhibitor. This July, Gilead and Galapagos forged another decade-long global research and development collaboration, marking the largest pipeline-building deal since Daniel O’Day assumed the role of CEO in March. This partnership is poised to strengthen Gilead’s position in the field of inflammatory diseases.

Molecular Structural Formula of Filgotinib

Also in July, Gilead held a pre-New Drug Application (NDA) meeting with the U.S. FDA regarding filgotinib. Gilead stated that it expects to submit an NDA to the FDA for filgotinib in the treatment of rheumatoid arthritis by the end of this year. Currently, Gilead and Galapagos are conducting multiple studies to evaluate the potential of filgotinib in treating various inflammatory diseases, including Phase III trials for Crohn’s disease and ulcerative colitis. EvaluatePharma previously released a report predicting that filgotinib will become one of the key products driving Gilead’s future growth, with global sales expected to reach $1.4 billion in 2024.

Reference Source: European Medicines Agency Validates Marketing Application for Filgotinib for the Treatment of Rheumatoid Arthritis