Resubmission of baricitinib NDA further delayed
Shares of Incyte Corp (Nasdaq: INCY) were down as much as 5.19% at $138.27 in pre-market trading after, along with partner pharma major Eli Lilly (NYSE: LLY), it announced a further delay in US approval of their rheumatoid arthritis drug candidate baricitinib. Lilly’s shares were down 1%.
Following receipt of a Complete Response Latter in April this year rejecting approval of the drug, the companies this morning announced that a resubmission to the US Food and Drug Administration for the New Drug Application (NDA) for baricitinib, a once-daily oral medication for the treatment of moderate-to-severe rheumatoid arthritis (RA), will be delayed beyond 2017.
The companies will be further discussing the path forward with the agency and evaluating options for resubmission, including the potential for an additional clinical study, as requested by the FDA. The length of time to a resubmission for the NDA will depend on which option the companies pursue and further FDA discussions, but is anticipated to be a minimum of 18 months.
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