Pfizer’s alopecia treatment receives Breakthrough Therapy designation

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”.
SEE ALSO:
-
Pfizer anticipates cost of preparing for impending Brexit could hit $100mn
-
European biopharma company BioNTech secures a $425mn influenza deal with Pfizer
-
Pfizer invests $465mn to develop new pharmaceutical production facility
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.
- Resilience & Reform Needed to Guard Healthcare Supply ChainsMedical Devices & Pharma
- Manufacturers Unite in the Battle Against Breast CancerMedical Devices & Pharma
- Pfizer Appoints AI Leader to Boost Digital TransformationTechnology & AI
- Shoddy Chinese Syringes Sees BD Ramp-up ProductionProcurement & Supply Chain
Featured Articles
NTT and medical technology company Olympus put on a demonstration, showing the IOWN APN's low-latency capability, for the first cloud endoscopy system
Richter BioLogics GmbH & Co KG's a new biopharmaceutical GMP facility in Germany will boost production capabilities and local employment
A pilot study from GE Healthcare has shown the value of Portrait Mobile Continuous Monitoring Solution, a leap in post-surgical monitoring efficiency