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Pfizer's Xeljanz Positive in Active Psoriatic Arthritis Study
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Pfizer Inc. (PFE - Free Report) announced top-line results from the second phase III study (OPAL Beyond) of the OPAL global clinical development program on Xeljanz (tofacitinib citrate) for the treatment of patients with active psoriatic arthritis (PsA).
The randomized, double-blind, placebo-controlled, six-month study evaluated the safety and efficacy of twice-daily dosage of Xeljanz (10 mg and 5 mg) in patients (n=395) with active PsA, who had inadequate response to at least one tumor necrosis factor inhibitor (TNFi) due to the lack of efficacy or an adverse event.
Data from the study demonstrated statistically significant improvement in patients dosed with Xeljanz compared to the placebo arm, thereby meeting the primary efficacy endpoints.
We remind investors that the company announced top-line results from the first phase III study (OPAL Broaden) in Apr 2016. The OPAL Broaden study has also met the primary efficacy endpoints and demonstrated superiority over placebo.
Results from both the studies (OPAL Broaden and OPAL Beyond) are expected to be presented at a scientific meeting in the future.
We note that Xeljanz is currently approved in the U.S. for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). In Feb 2016, the FDA approved an extended-release 11 mg tablet for the once-daily formulation of Xeljanz. The drug is currently approved in over 45 countries for the treatment of moderate-to-severe RA, as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs.
The company reported worldwide Xeljanz sales of $197 million in the first quarter of 2016, compared to $96 million in the first quarter of 2015.
Meanwhile, a Marketing Authorisation Application (MAA) for Xeljanz tablets (5 mg, twice daily) is currently under review in the EU for the treatment of patients with moderate-to-severe RA who have had an inadequate response or intolerance to MTX.
In addition, Xeljanz is being evaluated in phase III studies for the treatment of ulcerative colitis.
Pfizer currently sports a Zacks Rank #1 (Strong Buy). Bristol-Myers Squibb Company (BMY - Free Report) , Retrophin, Inc. and ANI Pharmaceuticals, Inc. (ANIP - Free Report) are three other favorably placed stocks in the health care sector, each carrying the same Zacks Rank as Pfizer.
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Pfizer's Xeljanz Positive in Active Psoriatic Arthritis Study
Pfizer Inc. (PFE - Free Report) announced top-line results from the second phase III study (OPAL Beyond) of the OPAL global clinical development program on Xeljanz (tofacitinib citrate) for the treatment of patients with active psoriatic arthritis (PsA).
The randomized, double-blind, placebo-controlled, six-month study evaluated the safety and efficacy of twice-daily dosage of Xeljanz (10 mg and 5 mg) in patients (n=395) with active PsA, who had inadequate response to at least one tumor necrosis factor inhibitor (TNFi) due to the lack of efficacy or an adverse event.
Data from the study demonstrated statistically significant improvement in patients dosed with Xeljanz compared to the placebo arm, thereby meeting the primary efficacy endpoints.
We remind investors that the company announced top-line results from the first phase III study (OPAL Broaden) in Apr 2016. The OPAL Broaden study has also met the primary efficacy endpoints and demonstrated superiority over placebo.
Results from both the studies (OPAL Broaden and OPAL Beyond) are expected to be presented at a scientific meeting in the future.
We note that Xeljanz is currently approved in the U.S. for the treatment of adults with moderate-to-severe active rheumatoid arthritis (RA) who have had an inadequate response or intolerance to methotrexate (MTX). In Feb 2016, the FDA approved an extended-release 11 mg tablet for the once-daily formulation of Xeljanz. The drug is currently approved in over 45 countries for the treatment of moderate-to-severe RA, as a second-line therapy after failure of one or more disease-modifying antirheumatic drugs.
The company reported worldwide Xeljanz sales of $197 million in the first quarter of 2016, compared to $96 million in the first quarter of 2015.
Meanwhile, a Marketing Authorisation Application (MAA) for Xeljanz tablets (5 mg, twice daily) is currently under review in the EU for the treatment of patients with moderate-to-severe RA who have had an inadequate response or intolerance to MTX.
In addition, Xeljanz is being evaluated in phase III studies for the treatment of ulcerative colitis.
Pfizer currently sports a Zacks Rank #1 (Strong Buy). Bristol-Myers Squibb Company (BMY - Free Report) , Retrophin, Inc. and ANI Pharmaceuticals, Inc. (ANIP - Free Report) are three other favorably placed stocks in the health care sector, each carrying the same Zacks Rank as Pfizer.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days.Click to get this free report >>