The U.S.A. Food and Drug Administration has approved Pfizer Inc's (PFE.N) drug to treat hair loss caused by an autoimmune disease, the company said on Friday.
The drug, branded as Litfulo, has been approved for people aged 12 years and older suffering from severe alopecia areata (AA), a condition where the immune system attacks hair follicles and causes hair to fall out, often in clumps.
The FDA's decision makes Litfulo the first to be allowed for the treatment of the condition in adolescents.
The drug, which will be available in the coming weeks, is also the second systemic treatment to gain approval after Eli Lilly's (LLY.N) Olumiant, used to treat the condition in adults.
"AA affects people of all ages, and not uncommonly, it affects adolescents and younger populations, so to have an approved agent for adolescents is a significant leap forward," said Brett King, associate professor of dermatology at Yale School of Medicine, ahead of the decision.
Systemic treatments usually target the cause of the disease and impact the entire body's function including the immune system. Other treatments for alopecia areata - which include oral steroids and topical medications - target only certain affected parts of the body.
AA affects 300,000 people in the U.S. each year. It gained increased attention after actor and talk show host Jada Pinkett Smith, who suffers from the condition, was at the center of a controversy at the Academy Awards in 2022.
Pfizer could price its product competitively with Olumiant, BMO Capital analyst Keith Tapper said before the approval.
Olumiant has a list price of $2,622 for a 30-day supply of 2-microgram tablets or $5,244 for a 30-day supply of 4-microgram tablets, according to Lilly's website.
Pfizer's application to the FDA was based on data from a mid-to-late-stage study that showed 80% or more hair coverage after six months of using the drug compared to a placebo.