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The Food and Drug Administration (FDA) announced Tuesday that it approved Olumiant oral tablets for adult patients who are affected by severe alopecia areata.
The move by the agency marks the first FDA approval of a systemic treatment for the disorder.
"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," Dr. Kendall Marcus, the director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, said in a statement. "Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata."
Commonly referred to as just alopecia, alopecia areata is an autoimmune disorder that develops when the body attacks its own hair follicles, which can cause hair loss anywhere on the body.
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According to the American Academy of Dermatology Association, it can begin at any age, although most people develop it during childhood or their teenage years.
There are several types of alopecia areata, including alopecia totalis and alopecia universalis.
The disorder, which impacts more than 300,000 Americans each year, often appears as patchy baldness.
The approval for the drug was granted to Eli Lilly.
The tablets are a Janus kinase (JAK) inhibitor, which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation.
Its efficacy and safety were tested in two randomized, double-blind and placebo-controlled trials.
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Participants had at least 50% scalp hair loss, as measured by the severity of alopecia tool, for more than half a year.
The patients either received a placebo, 2 milligrams of Olumiant, or 4 milligrams every day.
The FDA explained that the primary measurement of efficacy for both trials was the proportion of patients who had achieved at least 80% scalp hair coverage at week 36.
"In Trial AA-1, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 5% of the 189 patients who received a placebo. In Trial AA-2, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3% of the 156 patients who received a placebo," the FDA said.
The most common side effects associated with Olumiant include upper respiratory tract infections, headache, acne, high cholesterol, fatigue, nausea and weight increase.
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It was initially approved in 2018 as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis and is also approved for the treatment of COVID-19 in certain hospitalized adults.
It is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.