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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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."
A disappointing meeting with the FDA means "we no longer see a viable path to US approval in this indication,” said Gilead CEO Daniel O'Day, as Galapagos assumes sole responsibility for the commercialization of the JAK inhibitor in Europe.
The Belgian biotech has divested its drug discovery services unit in Croatia which was making a nice profit but was not a priority as Galapagos concentrates on setting up its commercial operations in Europe.