Gilead To File Filgotinib For RA in 2019, Earlier Than Forecast
Concerns the Galapagos-partnered JAK inhibitor would be held back by a testicular toxicity study have been calmed by positive FDA talks and a submission is due before the end of the year.
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Keeping Track: US FDA Has Clinical Questions For Tricida, Gilead And BioMarin; Enspryng And Winlevi Approved
The latest drug approval and decision news from the Pink Sheet’s US FDA Performance Tracker.
Sixteen applications are in line for US FDA decisions in August. Ten are novel agents.
On pace to file selective JAK1 inhibitor filgotinib for US approval in RA by year’s end, Gilead says the drug’s safety profile may allow for a labeling advantage compared with other drugs in the class.