Gilead Sciences investigational treatment for moderately to severely active rheumatoid arthritis won’t be approved by the U.S. Food and Drug Administration in current form, its partner Galapagos said. The FDA wants further data and has expressed concerns about the overall benefit/risk profile of the 200 mg dose, said Galapagos. Galapagos is entitled to an approval milestone of $100 million for the approval of filgotinib in the U.S., and as a result Galapagos revised its 2020 operational cash burn guidance to between €490 and €520 million.
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