FDA Approves Eli Lilly’s Alopecia Drug

The US Food and Drug Administration today approved a drug made by Eli Lilly to treat severe alopecia areata.

The agency granted approval to Olumiant, oral tablets used to treat patients with the disorder that often produces patchy baldness and affects more than 300,000 people in the US each year, the FDA said. Olumiant is a Janus kinase, or JAK, inhibitor, which blocks the immune system from attacking hair follicles. In a pair of trials, 17%-22% of patients who received 2 milligrams of Olumiant and 32-35% of patients who received 4 milligrams achieved adequate scalp hair coverage after 36 weeks, according to the FDA.

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, director of the Division of Dermatology and Dentistry at the FDA's Center for Drug Evaluation and Research. “Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Alopecia areata usually presents as a few small bald patches in the head, while severe cases can include loss of all body hair, including eyelashes.

Dr. Andrew Messenger of the University of Sheffield and Matthew Harries of the University of Manchester wrote in an accompanying editorial that the Eli Lilly trial results “are impressive” and the findings represent “the first published phase 3 trials of any treatment for this condition.”

Pfizer and Concert Pharmaceuticals are also nearing approval with similar JAK inhibitors, which are already on the market to treat rheumatoid arthritis and other autoimmune diseases.

Dr. Brett King, a Yale dermatology professor who was the principal investigator for the two Eli Lilly trials, said that when all three companies have drugs on the market patients who do not respond to one company's drug may be able to get a response from another company's treatment.

Olumiant's side effects included respiratory tract infections, headache, acne, high cholesterol, inflammation of hair follicles, fatigue, nausea, urinary tract infection, genital yeast infections, anemia, low white blood cell counts, abdominal pain, shingles and weight increase.