Gilead expects topline results available from a pair of trials testing the new treatment in 2021.
The US Food and Drug Administration (FDA) has sent a Complete Response Letter (CRL) to Gilead Sciences, requesting additional data before they can approve the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis.
The agency is requesting more data from the MANTA and MANTA-RAy studies before completing their review. Both studies are designed to assess whether the investigational treatment has an impact on sperm parameters.
The FDA also expressed concerns over the overall benefit and risk profile of the filgotinib 200 mg dose.
Gilead has indicated that topline results for both the MANTA and MANTA-RAy trials are expected during the first half of 2021.
“We are disappointed in this outcome and will evaluate the points raised in the CRL for discussion with the FDA. We continue to believe in the benefit/risk profile of filgotinib in RA, which has been demonstrated in the FINCH Phase 3 clinical program,” Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences, said in a statement.
While the FDA did not accept the NDA, the European Medicines Agency’s Committee for Medicinal Products for Human Use recently recommended marketing authorization for filgotinib in the EU for the treatment of adults with moderate to severe rheumatoid arthritis who have responded inadequately or are intolerant of 1 or more disease-modifying anti-rheumatic drugs.
Both Gilead and Galapagos NV are partners in the development of filgotinib, conducting several clinical trials including, the FINCH Phase 3 program in rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerative colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase 3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies in uveitis and in small bowel and fistulizing Crohn’s disease.