Gilead’s RA Hopeful Filgotinib Hit By Complete Response Letter
FDA Concerned About High Dose And Testicular Side Effects
Complete Response Letter is a major setback for Gilead and its partner Galapagos.
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After a difficult spell for the Belgian biotech, positive interim data from two key studies looking at testicular toxicity concerns over filgotinib suggest a pathway for potential future US approval of the Gilead-partnered JAK inhibitor for IBD.
The Galapagos and Gilead partnership has had a tough few months and the failure of ziritaxestat, plus the decision not to develop filgotinib Stateside for rheumatoid arthritis, is calling into question the merits of the whole collaboration for the US biotech.
Onno van de Stolpe has told Scrip it will take time to win investor confidence back after more disappointing news about the JAK inhibitor but Galapagos has "the pipeline and the cash in the organization to do so."