Lilly/Incyte RA candidate baricitinib gets CRL
Eli Lilly and Co. (NYSE:LLY) and Incyte Corp. (NASDAQ:INCY) said they received a complete response letter from FDA for an NDA seeking approval of once-daily oral baricitinib (LY3009104) to treat moderate to severe rheumatoid arthritis. According to the companies, FDA will require additional data to determine the appropriate dosing and "further characterize safety concerns across treatment arms." The companies said the timing of a planned resubmission will depend on further discussions with the agency.
Under the leadership of new President and CEO David Ricks, Lilly is relying on key launches to offset the loss of patent coverage for several top-selling drugs. Analysts have estimated that baricitinib could deliver more than $1 billion in sales by 2020. On Friday, Lilly reiterated its financial guidance for 2017 and mid-term guidance for the remainder of the decade (see BioCentury, Oct. 24, 2016)...