The medicine filgotinib by biotechnology Galapagos is not yet ready for approval in its present form in the United States. The US watchdog Food and Drug Administration (FDA) reported this to Galapagos partner Gilead using a so-called Complete Response Letter. Galapagos speaks in a reaction to a setback. If the drug was approved, the company would receive a $100 million payment.

The FDA has requested the dates of the MANTA and MANTA-RAy studies to conclude the review. These studies were designed to determine whether filgotinib has an impact on sperm parameters. The authority also expressed concerns about the overall risk-benefit profile of the filgotinib dose of 200 milligrams.

“I have news, today, we continue to believe that the filgotinib has the potential to be an effective new treatment option for patients with rheumatoid arthritis, a ziektegebied is still a significant unmet medical need,” according to the Galapagos.

Gilead is the marketing authorization holder for filgotinib in the United States and responsible for potential sales there. Galapagos had already taken the mileage payment into account in his estimates for this year. The company is now reviewing its expectations for the operational cash burn. It is expected to reach EUR 490 million to EUR 520 million this year.

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