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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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.
VP Rebecca Morison said the ankylosing spondylitis indication adds more evidence of Taltz's benefits. She noted Lilly believes there should be fewer steps before AS patients access IL-17 inhibitors.