Eli Lilly‘s Olumiant (baricitinib) received approval Monday from the U.S. Food and Drug Administration for the treatment of severe alopecia areata, making it the first systemic treatment for adults living with the disease.
The approval is based on positive results from the Phase III BRAVE-AA1 and BRAVE-AA2 trials, which involved 1,200 adult patients with severe alopecia areata. After a 36-week observation period, at least 80% scalp hair coverage was achieved in 17% to 22% of the patients who received 2 mg of Olumiant and in 32% to 35% who received 4 mg. These results are significant as those who took a placebo experienced only 3% to 5% scalp hair coverage.
In addition, 11% to 13% of patients who took 2 mg per day and 24% to 26% of those who took 4 mg per day experienced at least 90% hair coverage, versus just 1% to 4% of patients who were given a placebo. In terms of eyebrow and eyelash coverage improvements, patients given the 4 mg dose saw significant changes at week 36. Most treatment-emergent adverse events were mild or moderate, including headaches, high cholesterol levels, acne, fatigue, nausea, elevated liver enzyme levels and more.
Severe alopecia areata is characterized by a more than 50% scalp hair loss based on the Severity of Alopecia Tool (SALT). The disease garnered significant media attention recently when Will Smith slapped Chris Rock at the 2022 Academy Awards after the latter made a joke about Smith’s wife, actress Jada Pinkett-Smith, who suffers from alopecia.
Olumiant is available in 1 mg, 2 mg and 4 mg tablets, with the recommended adult dose being 2 mg per day, to increase to 4 mg if necessary. Patients who have nearly complete or total scalp hair loss, with or without eyebrow hair or eyelash loss, typically start therapy at 4 mg. Once patients respond positively to 4 mg, the dosage is decreased to 2 mg.
“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. Alopecia areata causes unpredictable hair loss that can be patchy or complete, and it affects people of all ages and ethnicities,” Brett King, M.D., Ph.D., F.A.A.D., lead investigator of the BRAVE-AA study said.
Lilly is making Olumiant accessible to many and is working with insurers to make it more affordable. Eligible patients can get help with out-of-pocket expenses through the Oluminant Together support program, which offers a savings card that enables users to pay as low as $5 per month with their insurance or $25 per month if their policy does not cover it. These savings cards are available at specialty pharmacies and for download via the Olumiant.com website.
“The approval of Olumiant can spark hope for many patients and encourage new treatment conversations with their doctors. The National Alopecia Areata Foundation wants more choices for our patient community and with the approval of Olumiant, there are now new treatment expectations being established in alopecia areata care,” Nicole Friedland, president and CEO of NAAF said.
