FDA stuns Lilly and Incyte with CRL for much-anticipated RA drug baricitinib

Fierce Pharma ------- Even with a three-month extension, Eli Lilly was unable to quell FDA concerns about the safety risks of its highly anticipated rheumatoid arthritis drug baricitinib. Instead, it received a complete response letter saying more work must be done. The Indianapolis-based drugmaker announced today that the FDA said it wants to see additional clinical data to get the doses right and to better characterize safety concerns for the once-daily oral medication for moderate-to-severe rheumatoid arthritis. Eli Lilly said it and partner Incyte disagree with the FDA’s conclusions, indicating it might be able to speed the resubmission with more discussion. It also said it was not changing its financial guidance for the year, or its mid-term guidance for the rest of the decade as a result of the delay. To learn more click on the picture below to read the article.