FDA approves Olumiant for alopecia areata
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The FDA has approved Olumiant, the first systemic medication for the treatment of alopecia areata, according to a press release.
Olumiant (baricitinib, Eli Lilly/Incyte) is a once-daily oral Janus kinase (JAK) inhibitor that has previously been approved for rheumatoid arthritis and atopic dermatitis.
“There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved medicine," Patrik Jonsson, Lilly senior vice president, president of Lilly Immunology and Lilly USA and chief customer officer, said in a statement to Healio. "Our mission is to make life better for people living with debilitating immune-mediated diseases, and we’re delighted about what this medicine, as a first-in-disease treatment, can mean for adults with severe alopecia areata.”
Data from the AA-1 and AA-2 randomized, double-blind, placebo-controlled trials were used to support the approval, according to the FDA.
The two trials found 22% and 17% of patients taking 2 mg of Olumiant daily and 35% and 32% of those taking 4 mg of Olumiant experienced at least 80% of scalp hair coverage by week 36, as compared with 5% and 3% of those in the two placebo groups.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” Kendall Marcus, MD, director of the division of dermatology and dentistry in the FDA’s Center for Drug Evaluation and Research, said in the release. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
The drug’s most common adverse events include upper respiratory tract infections, headache, acne and high cholesterol.
Olumiant carries a box warning regarding serious infections, malignancy, mortality, major adverse cardiovascular events and thrombosis. It is not recommended in combination with other JAK inhibitors, biologic immunomodulators, cyclosporin or other potent immunosuppressants.
Perspective
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FDA approval of baricitinib for severe alopecia areata (AA) is truly historic. Until now, there have been no approved treatments for AA, and the medicines that have been used in the past are largely ineffective.
In June 2014, my wife and pediatric dermatologist, Britt Craiglow, and I published a case report of a patient with severe AA who I treated with tofacitinib, a new medicine for rheumatoid arthritis at the time and the first JAK inhibitor for treatment of autoimmune/inflammatory diseases. That report garnered international attention, and patients came from all over the world for treatment. It was clear there was work to do.
We began the work and, almost 8 years to the day after that first report made the news, the first medicine for severe AA was FDA approved. And there are two more JAK inhibitors, ritlecitinib and deuruxolitinib, advancing toward FDA approval. This is so momentous.
FDA approval of baricitinib for severe AA is a huge step toward addressing the incredible unmet need for treatment of this often devastating disease. This is a day to celebrate!
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