The U.S. Food and Drug Administration approved the first systemic treatment, Olumiant (baricitinib) oral tablets, for adult patients with severe alopecia areata, a disorder that often appears as patchy baldness and affects more than 300,000 people in the U.S. each year, according to a news release.
Alopecia areata, commonly referred to as just alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps. 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.
The efficacy and safety of Olumiant in alopecia areata was 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 milligrams of Olumiant, or 4 milligrams of Olumiant every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80% scalp hair coverage at week 36.
Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. Olumiant comes with warnings and precautions including recommending close monitoring for the development of signs and symptoms of infection during and after treatment; evaluating patients for active tuberculosis infection and testing for latent tuberculosis prior to treatment with Olumiant; and the potential for viral reactivation. In addition, other warnings and precautions include hypersensitivity (allergic reactions), gastrointestinal perforations (tears in stomach or intestine), and laboratory abnormalities including low white and red blood cell counts, liver enzyme elevations and lipid elevations.
Olumiant received priority review and breakthrough therapy designations for this indication.
The FDA granted the approval of Olumiant to Eli Lilly and Company.