Eli Lilly files for FDA approval of baricitinib for moderately-to-severely active rheumatoid arthritis

Eli Lilly submitted a marketing application to the FDA for the oral once-daily selective JAK1 and JAK2 inhibitor baricitinib, which it is co-developing with Incyte, for the treatment of moderately-to-severely active rheumatoid arthritis, the companies announced Tuesday. Eli Lilly Bio-Medicines president David Ricks remarked "[our] collaboration with Incyte has produced a rigorous Phase III programme and, if approved, the potential of a promising new treatment option for people with [rheumatoid arthritis]."

In October last year, the drugmakers unveiled Phase III study data illustrating that baricitinib was superior to AbbVie's Humira (adalimumab) regarding ACR20 responses. The therapy was also found to display superiority to placebo in the previously announced RA-BEACON and RA-BUILD trials.

Under the terms of the agreement, Eli Lilly will pay Incyte a milestone payment of $35 million related to the submission of baricitinib for US approval, with the latter drugmaker also eligible for a milestone payment of $100 million upon regulatory approval of the drug, as well as sales-based milestone payments and royalties on global net sales. If approved, Eli Lilly will head all commercialisation activities for baricitinib.

The therapy is also in Phase II development for psoriasis, diabetic nephropathy, atopic dermatitis and systemic lupus erythematosus. For related analysis, read ViewPoints: Baricitinib could be Eli Lilly’s near-term bounce back play and ViewPoints: New FirstWord analysis suggests AbbVie's medical affairs experience could play pivotal role in JAK inhibitor market expansion.

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