Lilly and Incyte delay NDA resubmission for Olumiant in RA

Eli Lilly and Co. (NYSE:LLY) said it would delay beyond 2017 its plans to resubmit an NDA for Olumiant baricitinib (LY3009104). In April, FDA issued a complete response letter for Olumiant, a Janus kinase-1 (JAK-1) and JAK-2 inhibitor, to treat rheumatoid arthritis (RA) (see BioCentury, April 17).

Lilly and partner Incyte Corp. (NASDAQ:INCY) said FDA "has indicated that a new clinical study is necessary for a resubmission in order to further characterize the benefit/risk across doses, in light of the observed imbalance in thromboembolic events." The companies said they disagree with the agency's conclusions and will seek further discussions with FDA, but said they would not resubmit the candidate for at least 18 months...