Pfizer Inc. PFE announced the presentation of detailed results from two phase III studies on Xeljanz (tofacitinib citrate) from the Oral treatment Psoriasis Trials (OPT) program at the American Academy of Dermatology Annual Meeting.
The studies evaluated the efficacy and safety of Xeljanz for the treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. According to the pooled analysis of 16 week data from the OPT Pivotal #1 and OPT Pivotal #2 studies, the twice-daily dosage of Xeljanz tablets (10 mg and 5 mg) achieved superiority over placebo, thereby meeting the co-primary efficacy endpoints as well as the key secondary efficacy endpoints.
We note that Xeljanz is already approved for the treatment of patients suffering from moderately-to-severely active rheumatoid arthritis, who responded inadequately or are intolerant to methotrexate. Xeljanz can also be used as monotherapy or in combination with methotrexate or other nonbiologic disease-modifying anti-rheumatic drugs.
Currently, a supplemental new drug application (sNDA) for Xeljanz (10 mg and 5 mg tablets) is being reviewed by the FDA for the treatment of moderate-to-severe chronic plaque psoriasis in patients who are candidates for systemic therapy or phototherapy. An action from the FDA is expected by Oct 2015.
Pfizer believes that these results will strengthen the sNDA for Xeljanz in the U.S. According to the company, Xeljanz may potentially become the first oral treatment in a new class of medicines for moderate-to-severe psoriasis, if approved.
Meanwhile, Pfizer is conducting three other studies under the OPT Program – OPT Compare (phase III study comparing the efficacy and safety of Xeljanz twice daily to placebo and Enbrel twice weekly), OPT Retreatment (phase III study evaluating the efficacy and safety of withdrawal followed by re-treatment with Xeljanz twice daily compared to placebo) and OPT Extend (long-term extension study evaluating the safety and tolerability of Xeljanz).
Pfizer carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health acre sector are Cytokinetics, Inc. CYTK, ANI Pharmaceuticals, Inc. ANIP and Acorda Therapeutics, Inc. ACOR. All these stocks carry a Zacks Rank #1 (Strong Buy).
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