FDA to review Pfizer plaque-psoriasis test drug XELJANZ

Pfizer said on Wednesday that the U.S. Food and Drug Administration has accepted for review the supplemental New Drug Application (sNDA) for XELJANZ, a medication for treating moderate to severe chronic plaque psoriasis.

XELJANZ is a molecule believed to contribute to chronic inflammatory responses because it focuses on the Janus kinase inhibitor (JAK), a signaling path within the cells. XELJANZ is being studied as a possible treatment for patients with moderate to severe chronic plaque psoriasis, an immune-mediated inflammatory skin disease, who are contenders for phototherapy or systematic therapy.

“This regulatory milestone demonstrates our commitment to the research of chronic inflammatory diseases with the goal of developing therapies, such as XELJANZ, that can help address unmet medical needs for patients,” Steve Romano, Pfizer Global Innovative Pharmaceutical's Global Medicines Development unit head, said. “We continue to play a leadership role in the evaluation of JAK inhibition across chronic inflammatory diseases, such as psoriasis.

Data from the Phase 3 oral treatment psoriasis trials program convinced Pfizer to submit the application to the FDA. The global, multiple study clinical development program was made up of five studies that assessed XELJANZ in 3,600 patients with moderate to severe chronic plaque psoriasis.

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