FDA to review supplemental NDA for Xeljanz in adults with chronic plaque psoriasis

Pfizer announced that the FDA will review its supplemental new drug application for Xeljanz 5-mg and 10-mg tablets for the treatment of adults with moderate-to-severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy.

The FDA submission is based on data from a phase 3 global program consisting of five studies designed to evaluate oral Xeljanz (tofacitinib citrate) 5 mg and 10 mg twice daily in treating patients with moderate-to-severe chronic plaque psoriasis, according to a Pfizer press release. More than 3,600 adults from 36 countries were enrolled in the studies, making it one of the largest databases for potential psoriasis indication at the time of registration, the release stated.

Tofacitinib citrate, a small molecule that targets the Janus kinase pathway, is approved in the United States as 5 mg tablets for the treatment of adults with moderate-to-severe rheumatoid arthritis (RA) who have had inadequate response to methotrexate. It also is approved in 36 other countries for treatment of moderate-to-severe RA, according to the release.

The FDA is expected to decide on the supplemental NDA by October, according to the release.

Reference: www.pfizer.com.