FDA approves first daily pill to treat alopecia

by Will Tubbs

Lauren Dempsey, MS in Biomedicine and Law, RN, FISM News 


Earlier this month the U.S. Food and Drug Administration (FDA) announced its approval of an oral medication to treat adult patients diagnosed with alopecia areata, which affects hundreds of thousands of people in the United States.

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

The drug, Olumiant, is the first pill approved to treat the entire body rather than a targeted area for treatment of alopecia. Olumiant was originally approved in 2018 for treatment of Rheumatoid arthritis and in 2020 was granted an emergency use authorization (EUA) to be administered with remdesivir for hospitalized COVID-19 patients.

The two clinical trials, conducted by Lilly, showed that by 36 weeks, 17-22% of patients taking the 2mg daily dose of OLUMIANT and 32-35% of patients taking the 4mg daily dose of OLUMIANT had 80% or more scalp hair coverage, compared to 3-5% of trial participants that were taking a placebo.

The results also showed that 11-13% of participants were able to achieve 90% or more hair coverage when taking 2mg or 4mg daily when compared to 1-4% of participants taking the placebo.

“People with alopecia areata, dermatologists and other healthcare providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease,” said Dr. Brett King, associate professor of dermatology at Yale School of Medicine and lead investigator of the alopecia trials, which were called BRAVE-AA, “Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities.”

The trial results show that the drug is very effective at treating severe alopecia.

While the results are promising, the medication is not without side effects. The most common being respiratory infections, headache, acne, high cholesterol, urinary tract infection, liver enzyme elevations, inflammation of hair follicles, fatigue, nausea, genital yeast infections, anemia, low number of certain types of white blood cells, abdominal pain, shingles, and weight increase.

Olumiant may be contraindicated with certain medications and comes with warnings and precautions including close monitoring for any signs and symptoms of infection during and after treatment; patients should also be tested for active or latent tuberculosis testing, and the potential for viral reactivation.

Other warnings for the medication include allergic reactions, tears in the stomach or intestine, abnormal lab results, as well as elevated liver enzymes and lipids. Olumiant also comes with a boxed warning that includes “serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.”

According to the National Alopecia Areata Foundation there are as many as 6.8 million people in the U.S. affected by alopecia with a lifetime risk of 2.1%. Alopecia is an autoimmune disease where the body attacks hair follicles which causes hair loss and usually affects the head and face; however, researchers still aren’t sure what causes it.

Alopecia affects men and women, every ethnic group, and can occur at any age.  Typically hair loss occurs in patches about the size of a quarter, but it can be more severe resulting in loss of hair on the scalp or the entire body. Researchers are hopeful that Olumiant will help patients with this disorder.