-=Gilead Sciences (GILD) receives a Complete Response Letter from the FDA for its Filgotinib drug

• Gilead teamed up with Galapagos (GLPG) on development of the investigational drug in 2015.
• Investors were counting on filgotinib becoming a blockbuster for Gilead and generating billions of dollars over the long run for Galapagos.

Gilead Sciences receives Complete Response Letter from FDA for Filgotinib

Co announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for the New Drug Application (NDA) for filgotinib, an investigational treatment for moderately to severely active rheumatoid arthritis.

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.

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.

Briefing note - Under the terms of the agreement with Gilead, Galapagos (GLPG) 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.