The FINCH Phase III programme has been designed to investigate the efficacy and safety of filgotinib, in early-stage to biologic-experienced RA patient populations
Image: Galapagos and Gilead have partnered to develop filgotinib. Photo: Courtesy of mwooten from Pixabay.
Industry partners Gilead Sciences and Galapagos have jointly announced the 52-week data from the registrational Phase III FINCH 1 and FINCH 3 trials of filgotinib for the treatment of rheumatoid arthritis (RA).
Filgotinib is an investigational, oral, selective JAK1 inhibitor used for the treatment of moderately-to-severely active rheumatoid arthritis (RA).
Data from the clinical trials showed that filgotinib is consistent in treating RA and supports the efficacy, safety and tolerability profiles, as in the 12 and 24 weeks.
Gilead Sciences inflammation and respiratory diseases senior vice-president John Sundy said: “We are encouraged by the durability of both the efficacy and safety profiles of filgotinib seen in these studies. These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.”
The European Medicines Agency (EMA) is evaluating the Marketing Authorization Application (MAA) for filgotinib, and a New Drug Application (NDA) has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW) for filgotinib.
Gilead intends to file an NDA for filgotinib in the US
The FINCH Phase III programme has been designed to investigate the efficacy and safety of 100mg and 200mg filgotinib, in early-stage to biologic-experienced RA patient populations.
FINCH 1 was a 52‑week, randomised, placebo- and adalimumab-controlled trial intended to evaluate the drug in combination with methotrexate (MTX). The study enrolled 1,759 adult patients with moderately to severely active RA and inadequate response to MTX.
FINCH 3 was a 52‑week, randomised trial involving 1,252 MTX-naïve patients to evaluate filgotinib 200mg alone and filgotinib 100mg or 200mg combined with methotrexate compared to methotrexate alone in methotrexate-naïve patients.
Galapagos and Gilead have established collaboration to develop and commercialise filgotinib in inflammatory indications.
The companies noted that filgotinib is an investigational agent and is not approved for use, as the safety and efficacy of the drug have not been established by any regulatory authority.
Galapagos chief medical officer Walid Abi-Saab said: “These recent updates from the FINCH 1 and 3 trials continue to provide consistent evidence to support filgotinib’s profile in RA patients.
“In the second half of the FINCH 1 and FINCH 3 trials, filgotinib exhibited the same favorable safety profile seen in the first 24 weeks, including similar rates of thrombotic events as previously observed, as well as persistent efficacy.”