Gilead Submits NDA for Filgotinib as Fourth JAK Inhibitor in Japan

Compiled by Fan Dongdong

Gilead Sciences has recently submitted an application to Japanese regulatory authorities for the approval of filgotinib.

This drug is a highly selective JAK1 inhibitor discovered and developed by Galapagos. In late 2015, Gilead Sciences entered into a $2 billion collaboration agreement with Galapagos to co-develop filgotinib. In 2019, filgotinib reached a milestone in its development.

In March this year, Gilead and Galapagos announced the results of the FINCH 3 study, a pivotal Phase 3 clinical trial evaluating filgotinib for the treatment of rheumatoid arthritis. This randomized, double-blind, active-controlled study enrolled 1,252 adult patients with moderate to severe active rheumatoid arthritis who had not previously received methotrexate, assessing the efficacy and safety of filgotinib both as monotherapy and in combination with methotrexate. The results demonstrated that the combination therapy of filgotinib plus methotrexate exhibited significant efficacy compared with methotrexate alone.

In August, Gilead and Galapagos announced that the European Medicines Agency (EMA) had accepted the marketing authorization application for filgotinib for the treatment of rheumatoid arthritis in adults, and European regulators are currently evaluating the drug. Previously, Gilead held a pre-NDA meeting with the U.S. FDA regarding filgotinib, and the company stated that it expects to submit the application for filgotinib for the treatment of rheumatoid arthritis by the end of the year.

Currently, filgotinib is poised to become the fourth JAK inhibitor launched in Japan. Although other products have occupied the market for some time, Gilead and Galapagos remain confident in the drug’s future, believing that filgotinib has the potential to catch up and surpass competitors in the Japanese, European, and U.S. markets. EvaluatePharma previously issued a report predicting that filgotinib would become one of the key drivers of Gilead’s future growth, with global sales reaching $1.4 billion in 2024.

Notably, the side effects of JAK inhibitors have remained a key concern in patient treatment. In July, the FDA added a boxed warning to Pfizer’s Xeljanz labeling, indicating that use of this drug may increase the risk of fatal blood clots. Due to safety concerns, Eli Lilly’s Olumiant was approved by the FDA only at a low 2 mg dose, and its labeling includes warnings about the potential for serious infections, cancer, and thrombosis. AbbVie’s Rinvoq was similarly affected, with its labeling also carrying warnings about the risk of serious thrombosis. However, Pfizer is currently developing abrocitinib, an upgraded successor to Xeljanz, which had previously been granted Breakthrough Therapy designation by the FDA and is considered capable of mitigating, to some extent, the thrombotic risks commonly associated with current JAK inhibitors.

Reference Source:

1、Chasing AbbVie, Gilead files for approval of filgotinib in Japan

2、Gilead Sciences Submits New Drug Application for Filgotinib for the Treatment of Adults With Rheumatoid Arthritis in Japan

3、Gilead Sciences Submits New Drug Application for Filgotinib for the Treatment of Adults With Rheumatoid Arthritis in Japan