Pfizer Inc. (NYSE:PFE): Xeljanz Up Next For Active Psoriatic Arthritis Patients

Andy Parker
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Pfizer Inc. (NYSE:PFE): Xeljanz Up Next For Active Psoriatic Arthritis Patients

Pfizer Inc. (NYSE:PFE) has been quietly evaluating Xeljanz in a pair of Phase 3 trials as an oral treatment for patients afflicted by active psoriatic arthritis (PsA) and who have failed to see success with other treatment options. The company has shared detailed results from the two late-stage studies and will be shedding more light on the data at the annual ACR/ARHP meeting.

Target patients

Pfizer’s Xeljanz is already approved by the FDA as a treatment for a subset of psoriatic arthritis patients. As such, the studies that Pfizer has been carrying out on the drug are designed to expand its label, thus increasing its revenue potential.

Specifically, the latest pair of Phase 3 studies dubbed OPAL Broaden and OPAL Beyond tested the drug on active PsA patients who failed to respond well to disease-modifying antirheumatic drugs and tumor necrosis factor inhibitors. Pfizer wanted to find out if Xeljanz could be of help to this group of patients.

Study outcome

The company said the Phase 3 trials met their primary efficacy endpoints, which was statistically significant improvement in the conditions of active PsA patients with twice-daily doses of Xeljanz 5 mg and 10 mg. After three months of study, Xeljanz produced better results than placebo, strengthening Pfizer’s hopes of expanding the drug’s label.

Other than meeting efficacy targets, Pfizer said Xeljanz was also well tolerated as its safety results in the latest studies were consistent with safety results in the prior trials.

Huge addressable market

Pfizer estimates that more than 3 million people in the U.S. and Europe have active PsA. As such, approval of Xeljanz for the indication would be a blessing for these patients besides being a revenue boost for the company.

Xeljanz is already approved in the U.S. as a treatment for moderate-to-severe active rheumatoid arthritis in adult patients who have failed methotrexate treatment. The drug can also be used in combination with methotrexate for another condition.

For the cases it has been approved for, Xeljanz managed to generate $649 million in revenue for Pfizer in the first nine months of 2016, indicating 85% improvement from the same period last year.