The United States approves the first tablet to treat severe baldness
The United States Food and Drug Administration (FDA) approved the oral tablets for the treatment of severe alopecia areata in adults, a disorder that often appears as patchy baldness and affects more than 300,000 people in the United States annually.
In a statement, the FDA announced that the approval of the new drug called ‘baricitinib’, developed by Eli Lilly laboratories under the trade name Olumiant, means the agency’s first endorsement of a systemic treatment for alopecia areata, that is, it treats the entire body rather than a specific location.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Dr. Kendall Marcus, director of the Division of Dermatology and Dentistry at the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fill a significant unmet need for patients with severe alopecia areata,” he said.
Alopecia areata, commonly known as alopecia, is a autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out often in tufts.
The new drug inhibits the ‘Jano kinases’, a family of proteins that are part of the cytokine receptor enzymes, which interfere with the pathway that leads to inflammation.
The agency explained that the efficacy and safety in alopecia areata studied in two randomized, double-blind, placebo-controlled trials (Study AA-1 and Study AA-2) with patients who had at least 50% scalp hair loss as measured by the severity of the Alopecia Tool for more than six months.
Patients in these trials received a placebo, 2 milligrams of Olumiant, or 4 milligrams of Olumiant every day. The main measure of efficacy for both trials was the proportion of patients who achieved at least 80% hair coverage of the scalp at week 36.
The FDA noted that the drug was originally approved in 2018 as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis. It is also approved for the treatment of Covid-19 in certain hospitalized adults. The treatment has now received Priority Review and Breakthrough Therapy designations for baldness.