Galapagos (Nasdaq: GLPG) announces today that Gilead Sciences, Inc. (Nasdaq: GILD) received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis (RA). The FDA issues CRLs to indicate that the review cycle for an application is complete and that the application is not ready for approval in its present form. Gilead is the market authorization holder for filgotinib in the United States and is responsible for potential commercialization in the U.S.

The FDA has requested data from the MANTA and MANTA-RAy studies before completing its review of the NDA. The MANTA and MANTA-RAy studies are designed to assess whether filgotinib has an impact on sperm parameters. The FDA also has expressed concerns regarding the overall benefit/risk profile of the filgotinib 200 mg dose.

“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,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences.

“This CRL issued by the FDA is very disappointing given the robust and comprehensive data package provided. 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,” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.

The MANTA and MANTA-RAy studies are fully recruited, with topline results anticipated in the first half of 2021. Filgotinib is currently under review by regulatory authorities around the world. Filgotinib recently received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use, recommending marketing authorization for filgotinib in the EU for the treatment of adults with moderate to severe RA who have responded inadequately or are intolerant of one or more disease-modifying anti-rheumatic drugs.

Under the terms of the agreement with Gilead, Galapagos is entitled to an approval milestone of $100 million for the approval of filgotinib in the US, which was included in the Galapagos cash burn guidance. Following this CRL, Galapagos revises its full year 2020 operational cash burn guidance to between €490 and €520 million.