Gilead’s oral JAK inhibitor filgotinib wins EU approval

Gilead Science’s Galapagos-partnered oral JAK inhibitor filgotinib has been approved by the European Commission under the brand name Jyseleca for the treatment of moderate-to-severe active rheumatoid arthritis (RA).

Specifically, Jyseleca has been indicated for the treatment of adult patients with moderate-to-severe RA who have responded inadequately to, or who are intolerant to, one or more disease-modifying anti-rheumatic drugs. Gilead’s drug can be used as a monotherapy or in combination with methotrexate, and immune system suppressant.

The EU marketing authorisation is based on data from over 3,500 patients treated with filgotinib across the phase III FINCH and phase II DARWIN programmes. In all three FINCH trials, Gilead’s drug met the primary endpoints and consistently achieved relevant treatment targets.

Across both the FINCH and DARWIN trials, once-daily filgotinib demonstrated a consistent clinical safety profile when administered as monotherapy or in combination with methotrexate.

“RA affects in excess of 400,000 people – young and old – across the UK, with symptoms including pain, joint swelling and stiffness as well as chronic fatigue that can all lead to potential mental health issues and financial hardship,” said Clare Jacklin, chief executive officer of the National Rheumatoid Arthritis Society (NRAS).

“New options that can help alleviate symptoms are sorely needed and we therefore welcome today’s news as another important step forward for lessening the burden of RA on the individual, their families, the health service and the economy,” she added.