FDA Approves Baricitinib for Adults With Severe Alopecia Areata

Baricitinib (Olumiant; Eli Lilly and Company) is the first systemic treatment to be approved by the FDA for severe alopecia areata, which affects an estimated 300,000 patients in the United States.

The FDA has approved baricitinib (Olumiant; Eli Lilly and Company) tablets for the treatment of adults with severe alopecia areata. The approval marks the first systemic treatment to be given the greenlight by the FDA for severe alopecia areata, which affects an estimated 300,000 patients in the United States.

Baricitinib was previously granted priority review and breakthrough therapy designations for this indication.

“There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved medicine,” said Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA, and chief customer officer, in an emailed statement. “Our mission is to make life better for people living with debilitating immune-mediated diseases, and we’re delighted about what this medicine, as a first-in-disease treatment, can mean for adults with severe alopecia areata.”

Alopecia areata is an autoimmune disorder that causes the to body attack its own hair follicles, which causes hair to fall out, frequently in clumps. The Janus kinase (JAK) inhibitor inhibits the activity of 1 or more of a specific family of enzymes to interfere with the pathway that leads to inflammation.

Baricitinib was evaluated in a pair of randomized, double-blind, placebo-controlled trials (Trial AA-1 and Trial AA-2) with patients who had experienced a minimum of 50% scalp hair loss as measured by the Severity of Alopecia Tool for more than 6 months. Individuals in both trials were administered either a placebo, 2 milligrams of baricitinib, or 4 milligrams of baricitinib daily. The primary efficacy measurement across trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.

In Trial AA-1, 22% of 184 patients in the baricitinib 2 milligrams cohort and 35% of 281 patients in the baricitinib 4 milligrams cohort achieved adequate scalp hair coverage, versus 5% of 189 patients in the placebo group. In Trial AA-2, 17% of 156 patients in the baricitinib 2 milligrams cohort and 32% of 234 patients in the baricitinib 4 milligrams cohort achieved adequate scalp hair coverage, versus 3% of 156 patients in the placebo cohort.

The most common adverse effects associated with baricitinib include upper respiratory tract infections; headache; acne; hyperlipidemia; increased creatinine phosphokinase; urinary tract infection; elevated liver enzymes; folliculitis; fatigue; lower respiratory tract infections; nausea; Candida infections; anemia; neutropenia; abdominal pain; herpes zoster; and weight gain.

Baricitinib use is not recommended in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.

Baricitinib carries warnings such as recommended close monitoring for the development of the symptoms of infection during and post treatment; evaluation for active tuberculosis infection and testing for latent tuberculosis before administration of baricitinib; and the potential for viral reactivation. Further warnings and precautions include hypersensitivity, gastrointestinal perforations, and laboratory abnormalities such as low white and red blood cell counts, liver enzyme elevations, and lipid elevations.

The drug carries a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.

Baricitinib was previously approved as a treatment for certain patients with moderately to severely active rheumatoid arthritis and for the treatment of COVID-19 in certain hospitalized adults.

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


FDA Approves First Systemic Treatment for Alopecia Areata. FDA. News release. June 13, 2022. https://www.fda.gov/news-events/press-announcements/fda-approves-first-systemic-treatment-alopecia-areata