Eli Lilly said enough to convince an FDA advisory panel that its experimental rheumatoid arthritis drug is effective in treating the inflammatory disorder. But on safety, the independent experts were not uniformly persuaded, and they voted to recommend approval only for the lower of two doses. It’s the second time the Lilly drug is up for an approval decision in the past two years.
Of the independent panel’s 15 members, 10 voted against approving Lilly drug baricitinib (Olumiant) at the 4 mg dose based on risks of the pill versus its benefit. But at the 2 mg dose, the vote was 10-5 in favor of approving the drug. Advisory panels votes are not binding, but the FDA considers them when making decisions.
Shares of Indianapolis-based Eli Lilly (NYSE: LLY) dipped 1.15 percent to $79.28 in after-hours trading. Incyte (NASDAQ: INCY), the Wilmington, DE, company that licensed baricitinib to Lilly, saw its stock price fall 3.5 percent to $64.75.
Safety also was the chief concern one year ago, when the FDA rejected baricitinib and called on Lilly to provide more data. According to FDA briefing documents released last week in advance of Monday’s panel, the agency was concerned that patients taking the drug could develop blood clots. Specifically, some patients who took the higher dose of the Lilly drug had an increase in platelet counts, which can lead to blood clots.
Baricitinib is a once-a-day pill developed to block two Janus kinase (JAK) enzymes associated with inflammation. The Lilly drug follows a Pfizer (NYSE: PFE) drug, tofacitinib (Xeljanz), a JAK inhibitor that won FDA approval in 2012 as treatment for rheumatoid arthritis patients who had failed to respond to an earlier, first-line treatment for the disease. Lilly is trying to win FDA approval for its drug as a first-line rheumatoid arthritis treatment. The company is also angling to compete against the AbbVie (NYSE: ABBV) drug adalimumab, an injectable rheumatoid arthritis treatment that is a blockbuster seller with more than $18 billion in 2017 sales.
Lilly’s drug bested AbbVie’s treatment in head-to-head clinical trial results that were published last year in the New England Journal of Medicine. But that was at the higher, 4 mg dose of baricitinib, which is why the advisory panel’s vote against approving the Lilly drug at 4 mg is significant. If the FDA approves only the 2 mg dose of baricitinib, analysts have said Lilly will have a harder time competing against AbbVie’s drug.