FDA Sets Next Date For Incyte Arthritis Drug, Baricitinib

The Food and Drug Administration today announced that its Arthritis Advisory Committee will meet on April 23 to discuss the application by Incyte (INCY) and Eli Lilly (LLY) for approval of baricitinib for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have not responded adequately to or are intolerant of methotrexate. The committee will pass on a recommendation to the FDA itself, which will make the final determination.

The approval (which I see as likely but not guaranteed) of baricitinib, after the agency asked the companies for more information (which required expanded clinical trials), is the next and final hurdle for what could be a blockbuster drug for the treatment of rheumatoid arthritis.

Incyte shares are part of my Jubak Picks Portfolio. Incyte call options are part of my Volatility Portfolio.

Full disclosure: I own shares of Incyte in my personal portfolios.