Gilead and Galapagos’ application seeking approval for their oral JAK1 inhibitor filgotinib as a treatment for ulcerative colitis has been validated by the European Medicines Agency (EMA).
The proposed indication for filgotinib is for the treatment of adults with moderately to severely active ulcerative colitis (UC) who have had an inadequate response with, have lost response to, or were intolerant to conventional therapy or a biologic agent.
The application is supported by data from the phase IIb/III SELECTION study, which demonstrated a statistically significant higher proportion of patients treated with filgotinib 200mg achieving clinical remission at week 10 and maintaining remission at week 58 compared to placebo.
In addition, a statistically higher proportion of patients treated with filgotinib 200mg achieved endoscopic, histologic and six-month, corticosteroid-free remission at week 58 compared with placebo.
"Today's news from the EMA is a welcome step forward in our work aiming to improve outcomes for people living with inflammatory diseases, many of whom struggle with ongoing symptoms and are in need of new treatment options," said Mark Genovese, senior vice president, inflammation, Gilead Sciences.
"We are very pleased to have achieved this important milestone with filgotinib, building on its recent regulatory approvals in rheumatoid arthritis in the EU and Japan, as we bring this potential new treatment option one step closer for people living with UC," said Walid Abi-Saab, chief medical officer, Galapagos.
Filgotinib is already approved in the European Union as Jyseleca for the treatment of patients with moderate-to-severe active rheumatoid arthritis who have responded inadequately or are intolerant to one or more disease modifying anti-rheumatic drugs (DMARDs).