Gilead has announced that it has received the approval for Jyseleca (filgotinib) from the regulatory authorities in the European Union and Japan.
The European Commission in Europe and the Japanese Ministry of Health, Labour, and Welfare (MHLW) in Japan approved the product in adult patients with rheumatoid arthritis. In Europe, the product received approval for patients who have responded inadequately or intolerant to one or more disease-modifying anti-rheumatoid drugs (DMARDs). Japan label says that the product is approved for patients who had an inadequate response to conventional therapies.
The approval in both the regions is based on the global FINCH Phase 3 and DARWIN Phase 2 trials. Gilead enrolled more than 3,500 patients in both the trials to demonstrate the efficacy of the product. The trials included both the patients who were treatment naïve and patients who had an inadequate response to standard therapy including biologics.
The FINCH-3 program included patients who were treatment naïve to biologic experience patients. Jyseleca + methotrexate was compared with adalimumab + methotrexate. Two doses of the products were evaluated in the randomized, double-blind, active, and placebo-controlled study. FINCH-3 trial enrolled 1,759 patients who had an inadequate response to methotrexate. ACR 20 response at week 12 was considered as the primary endpoint. 76.6% of patients who were on filgotinib 200 mg and 69.8% of patients who were on filgotinib 200 mg achieved the primary endpoint compared to 70.8% in patients who were on adalimumab arm.
Gilead is responsible for supplying the drug in Japan, and Eisai is responsible for distributing the drug.
Gilead developed the product in combination with Galapagos.
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