Blow for baricitinib blockbuster hopes as higher dose deemed too dangerous

The advisory panel of the US Food and Drug Administration has delivered a mixed verdict on Eli Lilly (NYSE: LLY) and Incyte’s (Nasdaq: INCY) experimental rheumatoid arthritis therapy baricitinib, backing the use of the drug at a lower dose, while raising safety concerns over its use at higher dosage levels.

The verdict constitutes a serious blow for the firms’ hopes for the JAK1 and JAK2 inhibitor, which the firms resubmitted to the American regulator after initially being rebuffed. Shares in both firms dropped in after hours trading on Monday.

The panel noted the efficacy of the drug at both dosages, and voted nine to six in favor of approving the lower 2mg dose, expressing the view that the benefits were greater than the risks.