ARTICLE | Company News

Lilly stretches Olumiant timeline, updates cancer strategy

July 26, 2017 2:08 AM UTC

Eli Lilly and Co. (NYSE:LLY) reported 2Q17 earnings and said it would delay its plans to resubmit an NDA for Olumiant baricitinib beyond 2017. The company also said it would narrow its oncology focus to prioritize a handful of compounds, and would seek to partner others.

In April, FDA issued a complete response letter for Olumiant, a Janus kinase-1 (JAK-1) and JAK-2 inhibitor, to treat rheumatoid arthritis. On Tuesday, 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 estimated that they would not resubmit the candidate for at least 18 months...