FDA Approves Pfizer’s Drug for Hair Loss Caused by Autoimmune Disease

(CTN News) – The U.S. Food and Drug Administration (FDA) has approved Pfizer Inc’s (PFE.N) drug, Litfulo, for treating hair loss caused by an autoimmune disease.

Litfulo, the brand name for the drug, is now authorized for individuals aged 12 years and older suffering from severe alopecia areata (AA), a condition characterized by the immune system attacking hair follicles, resulting in hair loss in clumps.

Pfizer’s Litfulo and Eli Lilly’s Olumiant as Systemic Treatments for Alopecia Areata

This groundbreaking decision by the FDA marks the first approval of a drug specifically for treating alopecia areata in adolescents. Before this, the only systemic treatment available for adults was Eli Lilly’s (LLY.N) Olumiant.

Associate Professor of Dermatology at Yale School of Medicine, Brett King, highlighted the significance of this approval, stating, “AA affects people of all ages, and not uncommonly, it affects the adolescent and younger population, so to have an approved agent for adolescents is a significant leap forward.”

Systemic treatments such as Litfulo and Olumiant target the underlying cause of the disease and impact the body’s overall functioning, including the immune system.

In contrast, other treatments for alopecia areata, such as oral steroids and topical medications, only target specific affected areas of the body.

Alopecia areata affects approximately 300,000 people in the United States annually and gained increased attention when actor and talk show host Jada Pinkett Smith, who also suffers from the condition, was at the center of a controversy at the Academy Awards in 2022.

Pfizer’s Successful FDA Application: Efficacy Data and Clinical Study Results

Pricing comparisons suggest that Pfizer’s Litfulo may be competitively priced with Eli Lilly’s Olumiant, according to BMO Capital analyst Keith Tapper.

To support its FDA application, Pfizer provided data from a mid-to-late-stage study demonstrating that the use of Litfulo resulted in 80% or more hair coverage after six months compared to a placebo.

Litfulo is expected to be available in the coming weeks, offering new hope and an innovative treatment option for adolescents dealing with alopecia areata.