In a Complete Response Letter, FDA is requesting additional data from Gilead Sciences for its investigational treatment for moderately to severely active rheumatoid arthritis (RA).
The FDA is requesting additional data from Gilead Sciences for its investigational treatment for moderately to severely active rheumatoid arthritis (RA).
In the complete response letter (CRL), FDA requested data from the MANTA and MANTA-Ray studies before it completes its review of the New Drug Application for filgotinib. FDA also expressed concerns on the overall benefit/risk profile of the 200 mg dose of the therapy.
“We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA,” Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences, said in a statement. “We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical program.”
MANTA and MANTA-Ray are assessing whether filgotinib has an impact on sperm parameters. The topline results are anticipated in the first half of 2021.
Gilead and Galapagos NV are collaborative partners in the global development and commercialization of filgotinib in RA and other indications. Upon approval of filgotinib in the United States, Galapagos is entitled to $100 million.
“This CRL issued by the FDA is very disappointing given the robust and comprehensive data package provided,” Walid Abi-Saab, MD, chief medical officer, Galapagos, said in a statement. “Despite today’s news, we continue to believe filgotinib has the potential to provide an effective, new treatment option for patients with rheumatoid arthritis, where there remains a significant unmet need.”
In June, Gilead and Galapagos announced they had received a positive opinion from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP), which had been reviewing filgotinib 200 mg and 100 mg tablets.
The CHMP opinion was based on data from the phase 3 FINCH and phase 2 DARWIN programs. Across these trials, filgotinib taken once daily had a consistent clinical safety profile as a monotherapy or in combination with methotrexate. The therapy consistently met ACR20/50/70 targets. The CHMP opinion is being reviewed by the European Commission, which can authorize medicines in the European Union. A decision is expected in the third quarter of 2020.
Filgotinib is also being studied in the phase 3 SELECTION trial for ulcerative colitis, the phase 3 DIVERSITY trial for Crohn disease, the phase 3 PENGUIN trials in psoriatic arthritis, and in phase 2 studies for uveitis and in small bowel and fistulizing Crohn disease.