Gilead Sciences has filed the NDA for filgotinib based on the data from the Phase 3 FINCH clinical trial programme, which evaluated filgotinib as once-daily treatment
Image: Gilead Sciences seeks NDA approval for Filgotinib in Japan. Photo: Courtesy of Darko Stojanovic from Pixabay.
US-based biotechnology company Gilead Sciences has submitted a new drug application (NDA) to the Ministry of Health, Japan, seeking approval for filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of rheumatoid arthritis (RA) in adults.
The company has filed the NDA for filgotinib based on the data from the Phase 3 FINCH clinical trial programme, which evaluated filgotinib as once-daily treatment.
Gilead Sciences inflammation and respiratory diseases senior vice-president John Sundy said: “Despite multiple medications currently available to treat rheumatoid arthritis, there are still far too many people who do not experience adequate relief from their symptoms.
“The FINCH clinical trial program demonstrated that filgotinib may offer a wide range of people living with RA, including those in the early treatment and those who have tried standard therapies without success, an important new treatment option.”
FINCH clinical trials evaluated the safety and efficacy of filgotinib
The FINCH clinical trial showed that filgotinib has the potential to improve clinical symptoms, lower disease activity, and inhibit structural damage for patients living with RA.
The Phase 3 FINCH is a 52-week randomised clinical trial involving 1,252 MTX-naïve patients to evaluate filgotinib in combination with MTX, and as monotherapy.
The study evaluated the efficacy and safety of 100mg and 200mg filgotinib once daily in RA patient populations ranging from early-stage to biologic-experienced patients.
Gilead said that the safety data across the FINCH clinical trial programme was consistent with previously reported results. Since efficacy and safety of filgotinib have not been established by any regulatory authorities, the drug is an investigational agent and is not approved for use anywhere in the world.
Gilead Sciences president and representative director Luc Hermans said: “This new drug application is an important milestone as we continue to expand Gilead’s presence in Japan to now also include inflammation.
“We are committed to bringing innovative products to patients and healthcare providers in Japan, expanding beyond antivirals into new areas where our medicines can make a meaningful difference to patients.”