FDA approves alopecia treatment
The Food and Drug Administration (FDA) has approved a full-body treatment for alopecia areata, an autoimmune disorder that can cause hair loss and baldness occurring in patches on the body, for the first time.
The FDA announced in a release Monday that it has approved oral tablets called Olumiant as a treatment for adults with severe alopecia. The agency has previously approved treatments for the disorder that address specific parts of the body, but Olumiant is the first FDA-approved alopecia treatment that treats the entire body.
Alopecia affects more than 300,000 people in the U.S. every year, according to the release. In individuals with the disorder, the body attacks its own hair follicles, causing hair to fall out. The Olumiant treatment is designed to prevent that bodily response.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” Kendall Marcus, the 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.”
Researchers studied the treatment in two randomized trials with subjects who had at least 50 percent scalp hair loss for more than six months, the release states. The participants received either 4 milligrams or 2 milligrams of Olumiant or a placebo.
In one trial, more than 20 percent of patients who received 2 milligrams of Olumiant and more than a third of those who received 4 milligrams achieved 80 percent scalp hair coverage in 36 weeks, compared to only 5 percent who took the placebo.
In the other trial, 17 percent who received 2 milligrams of Olumiant and 32 percent who received 4 milligrams achieved the desired coverage, compared to 3 percent who took the placebo.
Olumiant had previously received approval from the FDA in 2018 as a treatment for patients with moderate to severe rheumatoid arthritis, according to the release. It is also an approved treatment for COVID-19 for certain adults who are hospitalized.
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