Breakthrough status from FDA for oral JAK3 inhibitor for alopecia areata

The US Food and Drug Administration has granted a coveted Breakthrough Therapy designation for a treatment for patients with alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.

The product in question is US pharma giant Pfizer’s (NYSE:PFE) investigational oral Janus kinase 3 (JAK3) inhibitors

The Breakthrough Therapy designation for alopecia areata was supported by positive results from a Phase II study, which will be presented during the late-breaking news session at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris on September 15, 2018. Currently, there are no FDA-approved treatments for alopecia areata, which impacts millions of people worldwide and is often associated with profound psychological consequences.