FDA approved Olumiant baricitinib from Eli Lilly and Co. (NYSE:LLY) and partner Incyte Corp. (NASDAQ:INCY) to treat moderate to severe rheumatoid arthritis in patients who have responded poorly to one or more TNF antagonists.
Lilly intends to launch Olumiant this quarter. A Lilly spokesperson told BioCentury the drug's wholesale acquisition cost will be about $25,000 annually, noting that the WAC is 60% less than that of Humira adalimumab from AbbVie Inc. (NYSE:ABBV).
In line with the recommendations of an FDA advisory committee, the drug's label recommends a 2 mg once-daily dose, but not a 4 mg once-daily dose for which Lilly also sought Olumiant's approval. Olumiant is approved as monotherapy or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs).
The Janus kinase-1 (JAK-1) and JAK-2 inhibitor's U.S. label includes a black box warning describing risks of serious infections, malignancies including lymphoma, and thrombosis. Lilly said it will conduct a postmarketing randomized controlled clinical trial to evaluate Olumiant's safety in RA patients.
Incyte is to receive a $100 million milestone payment triggered by the approval.
In April, FDA's Arthritis Advisory Committee voted 10-5 that the benefit-risk profile of 2 mg Olumiant was adequate to support the drug's approval, but voted 10-5 that the 4 mg dose's benefit-risk profile did not support its approval.
Olumiant is approved in the EU and Japan to treat RA. Lilly and Incyte received a complete response letter for Olumiant's original NDA in April 2017.
Lilly is relying on key launches, including Olumiant's, to offset the loss of patent coverage for several top-selling drugs (see BioCentury, Oct. 24, 2016).
Incyte was off $0.15 to $68.12 in afternoon trading Friday.