Breakthrough Therapy designation has been granted to the oral Janus kinase 1 (JAK1) inhibitor, PF-04965842 (Pfizer), for the treatment of patients with moderate-to-severe atopic dermatitis (AD).

PF-04965842 is an oral small molecule that selectively inhibits JAK1. In December, a Phase 3, randomized, double-blind, placebo-controlled trial (JADE) was initiated to evaluate the safety and efficacy of PF-04965842 in 375 patients aged ≥12 years with moderate to severe AD.

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“We look forward to working closely with the FDA throughout our ongoing Phase 3 development program with the hope of ultimately bringing this important new treatment option to these patients,” said Michael Corbo, CDO of Inflammation and Immunology, Pfizer.

Pfizer is also working on 3 other kinase inhibitors, which are each currently in Phase 2 development. These agents are intended to treat conditions such as psoriasis, rheumatoid arthritis, ulcerative colitis, and alopecia areata.

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