The U.S. Food and Drug Administration (FDA) has approved Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata. This action marks the first FDA approval of a systemic treatment for the condition.
Olumiant is a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Olumiant was originally approved in 2018. It is permitted as a treatment for certain adult patients with moderate to severely active rheumatoid arthritis. It is also used for the treatment of COVID-19 in certain hospitalized adults.
The FDA granted the approval of Olumiant to Eli Lilly and Company.
The efficacy and safety of Olumiant to treat alopecia areata were studied in two randomized, double-blind, placebo-controlled trials (Trial AA-1 and Trial AA-2) with patients who had at least 50% scalp hair loss, as measured by the Severity of Alopecia Tool for more than six months.
Patients in these trials received either a placebo, 2 mg of Olumiant or 4 mg of Olumiant daily. The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.
In Trial AA-1, 22% of the 184 patients who received 2 mg of Olumiant and 35% of the 281 patients who received 4 mg of Olumiant achieved adequate scalp hair coverage, compared with 5% of the 189 patients who received a placebo.
In Trial AA-2, 17% of the 156 patients who received 2 mg of Olumiant and 32% of the 234 patients who received 4 mg of Olumiant achieved adequate scalp hair coverage, compared with 3% of the 156 patients who received a placebo.
The most common side effects reported with Olumiant included: upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increase of creatinine phosphokinase, urinary tract infection, liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anemia, neutropenia, abdominal pain, shingles (herpes zoster) and weight increase.
Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Use of the product comes with warnings and precautions, including potential hypersensitivity, among others.
Notably, the product received priority review and breakthrough therapy designations for this alopecia indication.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the division of dermatology and dentistry in 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.”