Pfizer Inc.’s PFE New Drug Application (NDA) for its once-daily 11 mg once daily formulation of Xeljanz (tofacitinib citrate) has been accepted for review by the FDA. The company is looking to get the new formulation approved for the treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or are unable to tolerate methotrexate (MTX).
A response from the agency should be out by Feb 2016.
Pfizer had provided data from a clinical pharmacology program which was designed to show equivalence in key pharmacokinetic parameters to Xeljanz 5 mg twice daily.
We note that a 5 mg twice-daily formulation of Xeljanz, a Janus kinase (JAK) inhibitor, is already approved to treat adults with moderately to severely active rheumatoid arthritis in which methotrexate did not work well. Xeljanz is approved for use as a monotherapy or in combination with MTX or other non-biologic disease-modifying antirheumatic drugs (DMARDs)
Pfizer reported Xeljanz sales of $308 million in 2014. The company is working on expanding Xeljanz’s label. Xeljanz (10 mg and 5 mg twice-daily) is currently under FDA review for the treatment of patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. A response from the agency should be out by Oct 2015. Xeljanz is also being evaluated for ulcerative colitis and psoriatic arthritis.
Pfizer currently carries a Zacks Rank #3 (Hold). INSYS Therapeutics, Inc INSY and Eleven Biotherapeutics, Inc. EBIO and China Biologic Products, Inc. CBPO are better-ranked stocks in the health care sector, each carrying a Zacks Rank #1 (Strong Buy).
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