Pfizer Highly Recommended By Panel, Time For FDA Showdown

8/8/17

Recently, Pfizer (PFE) received a positive recommendation from a panel for its psoriatic arthritis drug XELJANZ (tofacitinib). The FDA Arthritis Advisory Committee (AAC) voted 10 to 1 to recommend for approval of the drug. The doses that Pfizer is seeking approval for is XELJANZ 5 mg twice daily (BID) and XELJANZ XR extended release 11 mg once daily (QD). In my opinion, this is highly positive for Pfizer, which is looking to expand its product variation for XELJANZ. XELJANZ is already approved by the FDA for the treatment of patients with moderate so severe rheumatoid arthritis. The FDA doesn't have to listen to the recommendation of the advisory panel, but I believe that the FDA has plenty of reason to approve the drug. The date on which the FDA will decide the fate of the drug is by December of 2017. This is not only important for Pfizer, but for patients as well. That is because if XELJANZ receives approval for this patient population, it will be the first Janus Kinase (JAK) inhibitor to do so.

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