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Lilly submits new drug application to FDA for baricitinib as RA treatment

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Eli Lilly and Company and Incyte Corp. announced in a press release that Lilly has submitted a new drug application to the FDA for its once-daily oral baricitinib as a treatment for moderate-to-severe rheumatoid arthritis.

Related to the submission, Lilly will pay $35 million to Incyte. Pending FDA approval, under the agreement between the companies, Incyte will receive a milestone payment of $100 million from Lilly, which will retain the global rights to commercialize baricitinib.

Baricitinib, a Janus kinase (JAK) 1 and JAK2 inhibitor, has undergone four phase 3 clinical trials for patients with rheumatoid arthritis (RA) and is currently in phase 2 studies for patients with systemic lupus erythematosus, psoriasis, atopic dermatitis and diabetic nephropathy.

“Lilly’s collaboration with Incyte has produced a rigorous phase 3 program and, if approved, the potential of a promising new treatment option for people with RA,” David Ricks, president of Lilly Bio-Medicines, said in the release.

Reference:

www.lilly.com