Gilead Sciences and Galapagos NV announced that Week 52 data from the registrational Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid arthritis (RA) are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the Week 12 and 24 analyses presented earlier this year.
“We are encouraged by the durability of both the efficacy and safety profiles of filgotinib seen in these studies,” said John Sundy, MD, PhD, Senior Vice President, Inflammation and Respiratory Diseases, Gilead Sciences. “These data suggest that filgotinib if approved, may play an important role in helping people living with rheumatoid arthritis achieve sustained, clinically meaningful responses.”
“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,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
Detailed Week 52 results from the FINCH 1 and 3 trials will be submitted for presentation at a future medical conference.
A Marketing Authorization Application (MAA) for filgotinib for the treatment of adults with rheumatoid arthritis is now under evaluation by the European Medicines Agency (EMA) and a New Drug Application (NDA) for filgotinib has been submitted to the Japanese Ministry of Health, Labor and Welfare (MHLW). Gilead plans to file a New Drug Application (NDA) for filgotinib for the treatment of rheumatoid arthritis in the United States including the FINCH 1 and FINCH 3 Week 52 data later this year.
Filgotinib is an investigational agent and is not approved anywhere. Its efficacy and safety have not been established by any regulatory authorities.
Source: Press Release