FDA Approves Olumiant to Treat Patients with Alopecia

The FDA has approved Eli Lilly’s Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia, a disorder that often appears as patchy baldness. This is the first FDA approval of a systemic treatment for alopecia, which affects more than 300,000 people in the United States each year.

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 approval is based on two placebo-controlled trials (BRAVE AA-1 and BRAVE 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.

In the first trial, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared with 5% of the 189 patients who received a placebo. In the second trial, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared with 3% of the 156 patients who received a placebo.No new safety issues where seen.

Brett King, M.D., Ph.D.

The analysis was published in the New England Journal of Medicine in May 2022 and presented at the 2021 European Academy of Dermatology and Venereology Congress.

“Whether people with alopecia areata suffer loss of all the hair on their body or bald spots and missing eyebrows or eyelashes, this autoimmune disease can be devastating. The disease affects people of all ages,” Brett King, M.D., Ph.D., associate professor of dermatology at Yale School of Medicine and lead author of these analyses, said in a press release.

Olumiant is a once-daily, oral JAK inhibitor that was discovered by Incyte and licensed to Lilly. It is approved in the United States and more than 75 countries as a treatment for adults with moderate to severe rheumatoid arthritis.

The labeling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis. In December 2021, the FDA required an updated boxed warning on the three top-selling JAK inhibitors — Pfizer’s Xeljanz Olumiant, and AbbVie’s Rinvoq (upadacitinib) — used to treat rheumatoid arthritis and other inflammatory conditions.

Related: FDA Requires New Boxed Warning on Xeljanz, other JAK Inhibitors

Olumiant is also approved in more than 50 countries, including the European Union and Japan, for the treatment of adult patients with moderate-to-severe atopic dermatitis.

In May 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Olumiant for the treatment of adults with severe alopecia.