Lilly and Incyte shoot for FDA approval with an oral RA drug

Partners Eli Lilly ($LLY) and Incyte ($INCY) filed an oral rheumatoid arthritis treatment for FDA approval, hoping to launch an agent that can steal market share from blockbuster injectables. The drug, baricitinib, works by blocking JAK1 and JAK2, a pair of kinases that play a role in the inflammatory process, and it bested AbbVie's ($ABBV) top-selling injectable Humira in a Phase III trial in RA. With the filing, Lilly and Incyte will now wait for the FDA to accept their application, a roughly 90-day process that then triggers a 10-month review. Incyte gets a $35 million milestone payment tied to the submission, and, under a partnership signed in 2009, the company is due up to $665 million and double-digit royalties on future sales of baricitinib. More

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