The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc’s drug to treat hair loss caused by an autoimmune disease, alopecia.
The drug, named Litfulo, has been approved for individuals aged 12 and older who suffer from severe alopecia areata (AA), a condition in which the immune system attacks hair follicles and causes hair loss.
The FDA’s decision makes Litfulo the first drug authorized for the treatment of the disease in adolescents.
The drug, which will be available in the coming weeks, is also the second systemic treatment to receive approval after Eli Lilly’s Olumiant, which is used to treat the disease in adults only.
“AA affects people of all ages and, not infrequently, affects the adolescent and younger population, so having an approved agent for adolescents is a significant leap,” said Brett King, associate professor of dermatology at Yale School of Medicine, to Reuters.
Systemic treatments generally target the cause of the disease and affect the function of the entire body, including the immune system. Other treatments for alopecia areata – which include oral steroids and topical medications – only target certain affected parts of the body.
AA affects 300,000 people in the U.S. each year. The disease gained more attention after actress and talk show host Jada Pinkett Smith, who suffers from the condition, was at the center of a controversy at the Oscars in 2022 when her husband, actor Will Smith, slapped another actor, Chris Rock, who had made a joke about Jada’s hair loss.
Pfizer will be able to set the selling price of its product to compete with Olumiant, which 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 the manufacturer’s website.
Due to the high price, the lack of health insurance will certainly put the treatment out of reach for many Americans.
Pfizer’s study showed that about 23% of patients regained 80% or more of hair coverage on the scalp after six months of treatment, compared to just 1.6% of participants in the placebo group. The most commonly reported side effects included headache, diarrhea, acne, rash, and hives, a rash characterized by itching, red welts, or skin-colored bumps.
Source: Reuters