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Pfizer’s alopecia treatment receives Breakthrough Therapy designation

Pfizer receives FDA approval for oral drug

In a press release on 5 September, Pfizer announced that its in-development investigational oral Janus kinase (JAK3) inhibitor PF-06651600 has been granted Breakthrough Therapy designation by the US Food and Drug Administration (FDA).

It is hoped that the inhibitor will aid in the treatment of alopecia areata, an autoimmune disease that causes hair loss around the body.

The designation was supported by success in a Phase 2 study, the positive results of which will be revealed at the 27th European Academy of Dermatology and Venerology (EADV) Congress in Paris on 15 September.

Pfizer’s press release noted that there are as yet “no FDA-approved treatments for alopecia areata, a condition which impacts millions of people worldwide and is often associated with profound psychological consequences”.


Michael Corbo, Chief Development Officer of Inflammation and Immunology for Pfizer Global Product Development, said:

“We are encouraged by this Breakthrough Therapy designation as it underscores the potential of our JAK3 inhibitor to address a critical unmet need”.

He added, “We are continuing to work closely with the FDA on the development process with the goal of bringing this potential new treatment to patients living with alopecia areata as soon as possible”.

“If a drug is designated as a Breakthrough Therapy, the FDA will expedite the development and review of such drug”, the press release continued.

In addition, Pfizer is discussing the clinical development programme for the JAK3 inhibitor with the European Medicines Agency.