FDA panel offers a wavering thumbs up for Eli Lilly's 2 mg baricitinib, thumbs down on 4 mg
A large panel of outside rheumatoid arthritis experts gathered at the FDA to discuss Eli Lilly’s $LLY controversial re-application for an approval of baricitinib, voting in lopsided favor of the efficacy and safety of the 2 mg dose of the rheumatoid arthritis drug, but turned their thumbs down on the 4 mg dose.
Ten voted in favor of the risk/benefit balance of the 2 mg dose, 5 against. The numbers were reversed for the 4 mg, falling 10 against and 5 in favor.
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.