STAT Plus: An expected blockbuster drug from Gilead is rejected, imperiling the biotech’s future growth
Back before remdesivir became a household name, Gilead Sciences’ most-discussed drug was filgotinib, a treatment for inflammatory disease expected to deliver billions of dollars in new revenue at a time when the biotech desperately needs it. All that got put in jeopardy on Tuesday night.
The FDA rejected Gilead’s application to sell filgotinib as a treatment for rheumatoid arthritis and said it wouldn’t reconsider until the company can provide more data on the drug’s effect on patients’ sperm counts. Gilead is running two studies to determine exactly that, but it won’t have results until sometime next year.
