Pfizer gains Breakthrough designation for PF-04965842 in atopic dermatitis

The once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 has received Breakthrough Therapy designation from the US Food and Drug Administration for the treatment of patients with moderate-to-severe atopic dermatitis (AD).

The Phase III program for PF-04965842 was initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program, notes the drug’s developer, US pharma giant Pfizer (NYSE: PFE).

“Achieving Breakthrough Therapy designation is an important milestone not only for Pfizer but also for patients living with the often devastating impact of moderate-to-severe atopic dermatitis, their providers and caregivers,” said Michael Corbo, chief development officer, inflammation and immunology, at Pfizer Global Product Development. “We look forward to working closely with the FDA throughout our ongoing Phase III development program with the hope of ultimately bringing this important new treatment option to these patients,” he added.