Olumiant finally gains FDA approval, but at a lower than optimal dose

The news of US approval for Olumiant (baricitinib), while clearly welcomed, was not as good as it could have been for the drug’s developers, Eli Lilly (NYSE: LLY) and Incyte (Nasdaq: INCY), which have already faced long delays, and it came with some caveats.

On Friday, the US Food and Drug Administration has approved the lower 2mg dose of Olumiant, a once-daily oral medication for the treatment of adults with moderately-to-severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) inhibitor therapies. It is also saddled with a ‘black box’ warning, the strongest that the US regulator can impose.

Analysts have said that a US approval of just the lower dose will limit the business opportunity for Lilly and Incyte, according to a Reuters report. Both the doses of the drug are approved in over 40 countries. In April, an FDA advisory panel voted against the preferred 4mg dose because of concerns about the safety profile of the drug.