News in English
The drug Olumiant (baricitinib) has now been approved for treating adult patients with severe alopecia areata, an autoimmune disease in which the body attacks its own hair follicles, leading to hair falling out, often in large tufts. In the United States, the disease affects over 300,000 people a year.
Olumiant is marketed by Eli Lilly and Company and is a JAK inhibitor that blocks the activity of certain enzymes, thus disrupting the process that leads to inflammation.
This is the first systemic treatment of the disease, and it thus targets the whole body rather than a limited area.
“The approval will help meet the yet unmet needs of patients with severe alopecia areata,” said Kendall Marcus, Director of the Division of Dermatology and Dentistry at the FDA’s Center for Drug Evaluation and Research, in a press release.
The efficacy and safety of the drug have been studied in two randomised, double-blind and placebo-controlled studies in alopecia patients with at least 50% hair loss. Up to 35% of patients reached the primary endpoint of at least 80% of scalp coverage after 36 weeks of treatment.
Some of the most common side effects of the treatment were upper respiratory tract infections, headaches, acne, high cholesterol and weight gain.
The drug is already approved for the treatment of certain adult patients with moderate to severe rheumatoid arthritis and also for treating certain hospitalised Covid-19 patients.