The US Food and Drug Administration (FDA) assigned the status of «breakthrough therapy» for the oral drug of JANUS-kinase 3 inhibitor class (JAK3) held by American pharmaceutical company Pfizer. The drug is designed to treat focal alopecia, a chronic autoimmune skin disease that causes hair loss on the scalp, face or body.
Assigning the status of «breakthrough therapy» for the treatment of focal alopecia was based on positive results of Phase II clinical trials. The status will speed up the development and evaluation of the product.
Millions of people suffer from focal alopecia all over the world. The consequences of the disease lead to deep psychological problems. Despite this, effective FDA-approved drugs for the treatment of condition are absent. The JANUS-kinase 3 inhibitor held by Pfizer can help to meet this critical medical need.
Pfizer also works with the European Medicines Agency under the clinical development program PF-06651600.
Focal alopecia is an autoimmune disease when immune cells attack healthy hair follicles causing hair loss.