FDA approves first oral tablet for alopecia treatment

The Food and Drug Administration approved Olumiant, a drug that restores hair growth and can act as a treatment for alopecia Monday.

Alopecia is an autoimmune disorder in which the immune system attacks hair follicles, resulting in hair loss on the scalp and, in some cases, the rest of the body.



This is the first systemic treatment for the disorder, which affects hundreds of thousands of people every year, said Dr. Adam Friedman, professor and chair of dermatology at The George Washington University School of Medicine and Health Sciences.

“This is extraordinary,” Friedman said. “Up until now, we’ve been using many different medications, all of which are not approved and being used off-label to manage this condition. But, we had nothing else.”

Friedman said patients have waited at least a decade for an FDA-backed treatment for moderate to severe alopecia areata.

Researchers believe a mix between genetics and environmental factors cause the disorder. More than 300,000 people are afflicted by it every year, according to Friedman.

“Having this approval will increase access to this medication for the thousands of people who have this condition,” he said.

The drug is an oral tablet called Olumiant and is manufactured by Eli Lilly. The drug blocks the immune system from attacking the body, causing inflammation that leads to hair loss.

Patients have been waiting for at least a decade for this kind of help, Friedman said.

“The fact that this condition is not as common as some other dermatologic diseases like acne or eczema, mixed with the fact that it’s extremely disabling to the patient, this led to it taking a while for the FDA to approve this medication,” he said.

Friedman said the approval is uplifting news for patients.

“This is a real medical problem. This is not a cosmetic issue,” he said. “And there is something out there that can help you.”

WTOP’s Kristi King contributed to this report. 

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