The U.S. Food and Drug Administration on Monday announced it approved a new drug to treat severe alopecia areata, an autoimmune condition that often leads to patchy hair loss on both the head and other parts of the body. 

What You Need To Know

  • The U.S. Food and Drug Administration on Monday announced it approved a new drug to treat severe alopecia areata

  • The drug, Olumiant, is a "systemic" pill, meaning it can treat the entire body rather than targeting a specific area for alopecia

  • Olumiant was developed by Eli Lilly in a series of randomized, double-blind trials in patients who had at least 50% scalp hair loss

  • According to the FDA release, severe alopecia areata affects around 300,000 individuals in the United States each year

The drug Olumiant is given via oral tablets, and is the first “systemic” treatment approved for the condition, per the FDA – meaning it can treat the entire body rather than targeting a specific area for alopecia. 

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

The Olumiant treatment was developed by Eli Lilly in a series of randomized, double-blind trials in patients who had at least 50% scalp hair loss for a period of six months or more. Patients were given either a placebo pill or a 2 milligram or ​​4 milligram dose of the drug for a period of 36 weeks. 

In one study, 35% of the patients who received the higher-dose regimen of Olumiant developed “adequate” hair coverage – which researchers defined as 80% of the scalp covered in hair – compared to 22% who received the lower dose. A second study showed 32% of the higher-dose trial patients had adequate hair coverage, as did 17% of the lower-dose patients at the end of the trial. 

Eli Lilly also saw improvements for patients with “substantial eyebrow and eyelash hair loss at baseline” when using the higher regimen of Olumiant. 

According to the FDA release, severe alopecia areata affects around 300,000 individuals in the United States each year. Scientists are unclear exactly what causes the body’s white blood cells to attack the hair follicles, but have posited that both genetics and the environment can play a role in the condition.

Alopecia can take a number of forms, the most common of which – alopecia areata – causes patchy or coin-sized areas of hair loss on the scalp or other hairy areas of the body. Should this patchy hair loss continue without becoming severe, it can be referred to as persistent patchy alopecia areata. Individuals with alopecia totalis experience hair loss across the entire scalp. 

Alopecia universalis is a more advanced form than the previously mentioned, as it results in hair loss typically across the entire head, face and body. While there is currently no cure for alopecia, treatments like topical corticosteroids can be used to treat localized patches of hair loss. 

“This is the dawn of a new era,” Nicole Friedland, president and CEO of the advocacy  group National Alopecia Areata Foundation, wrote in a statement. “For the first time, alopecia areata patients have the option of an approved treatment that has undergone rigorous testing in clinical trials. We anticipate more treatments to come, bringing additional choices to our community.”