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Baricitinib becomes the first Systemic Treatment for Alopecia Areata to be authorized by FDA

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eMediNexus    15 June 2022

Baricitinib (Olumiant), has become the first systemic treatment for alopecia areata to be approved by the FDA. It is a Janus kinase (JAK) inhibitor that stops one or more enzymes from working, producing inflammation in the hair follicles. Topical therapies were the only approved treatment module for alopecia areata. 

The results were drawn from two randomized, placebo-controlled clinical trials involving more than 1,000 patients. These participants were selected based on a minimum hair loss of 50% almost 6 months prior to the start of the therapy. They were randomly divided into two groups, the first group received a placebo, while the second was administered a single dose of Baricitinib regularly.

In one trial, 22% and 35% of patients were given different doses of Baricitinib satisfying the response criteria, compared to only 5% of those given placebo. In the second trial, one-third of patients who were treated with Baricitinib fulfilled response criteria, compared to only 3% of the placebo group. Thus the studies proved the effectiveness of systemic treatment using Baricitinib.

The therapy exhibited some common side effects. Also as a precautionary measure, the label had a boxed warning for serious infections, death, cancer, substantial adverse cardiovascular events, and thrombosis. (MedPage Today June 13, 2022)

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