- Eli Lilly (NYSE:LLY) gives shareholders some good news this morning with its announcement that, after discussions with the FDA, it plans to resubmit its New Drug Application (NDA) for rheumatoid arthritis (RA) med baricitinib by the end of January 2018. The refiling will include new safety and efficacy data.
- The company received a CRL in April citing the need for additional clinical data to support the optimum doses and additional data to further characterize the safety profile across treatment arms.
- In July, the company said it did not anticipate refiling for at least 18 months. It also believes the FDA will regard it as a Class II resubmission which has a six-month review cycle.
- Lilly co-developed baricitinib, an oral JAK inhibitor, with Incyte (NASDAQ:INCY), under a December 2009 agreement. It was approved in Europe in February and Japan in July.
- Previously: FDA rejects Lilly's marketing application for RA candidate baricitinib (April 14)
- Previously: Refiling of U.S. marketing application for arthritis med baricitinib at least 18 months away, Lilly down 1%, Incyte down 4% premarket (July 25)
- Now read: 3 Things In Biotech You Should Learn Today: August 25, 2017
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