Pfizer Inc. (PFE - Free Report) announced encouraging top-line results from two pivotal phase III studies from the Oral treatment Psoriasis Trials (OPT) Program (OPT Pivotal #1 and OPT Pivotal #2) on Xeljanz (tofacitinib:5mg and 10mg). Xeljanz, an oral Janus kinase (JAK) inhibitor, is being developed for the treatment of moderate-to-severe plaque psoriasis.
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Xeljanz showed statistically significant superiority at week 16 in the proportion of subjects achieving a Physician’s Global Assessment response of “clear” or “almost clear” over placebo. The candidate also showed superiority in the proportion of subjects achieving at least a 75% reduction in Psoriasis Area and Severity Index over placebo. Psoriasis Area and Severity Index are the two commonly used measures of efficacy in psoriasis.
In Oct 2013, Pfizer announced top-line data from the other two phase III studies (OPT Compare and OPT Retreatment) under the OPT Program evaluating Xeljanz (tofacitinib) for the treatment of adults with moderate-to-severe chronic plaque psoriasis.
Results from the OPT Compare study were mixed with Xeljanz (10 mg) meeting the primary endpoint of non-inferiority to Amgen’s (AMGN - Free Report) Enbrel but failing to meet the non-inferiority criteria to Enbrel at the 5 mg dose. Results from the OPT Retreatment study showed a higher number of patients who continued Xeljanz treatment maintained their response during the treatment withdrawal phase compared to patients who switched to placebo.
Based on the results from these four studies under the OPT Program and a long-term extension study, Pfizer plans to make regulatory submissions for Xeljanz in various countries for the treatment of adults suffering from moderate-to-severe chronic plaque psoriasis. Pfizer will filings a supplemental New Drug Application (sNDA) for Xeljanz in the U.S. in early 2015.
Xeljanz is already available in the U.S. for the treatment of moderate-to-severe active rheumatoid arthritis (RA) in adult patients who have not responded adequately to or cannot tolerate methotrexate (MTX). Xeljanz is the first oral treatment to gain approval in a new class of medicines known as JAK inhibitors. The product represents a new treatment option for patients who respond inadequately to or are unable to tolerate MTX. Xeljanz sales were $114 million in 2013.
We are encouraged by Pfizer’s progress with Xeljanz. Label expansion of the drug will boost its sales potential.
Pfizer, a large-cap pharma stock, currently holds a Zacks Rank #3 (Hold). Some better-ranked stocks in the same sector include Allergan Inc. (AGN - Free Report) and Johnson & Johnson (JNJ - Free Report) . Both sport a Zacks Rank #2 (Buy).