Pfizer announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to PF-06651600 for the treatment of patients with alopecia areata. 

PF-06651600 is an investigational oral Janus kinase 3 (JAK3) inhibitor that is being evaluated in a Phase 2 study which will assess the treatment based on changes from baseline in Severity of Alopecia Tool (SALT) score. The findings will be presented during a session at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris. JAK pathways are thought to be involved in inflammatory processes as they are in involved in signaling for >50 cytokines and growth factors.  

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“We are encouraged by this Breakthrough Therapy designation as it underscores the potential of our JAK3 inhibitor to address a critical unmet need,” said Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development. Currently, there are no FDA-approved treatments for alopecia areata.

PF-06651600 is also being studied for the treatment of rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. 

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