The US Food and Drug Administration approved the first systemic treatment for severe hair loss disorder Alopecia Areata.
The oral tablet, baricitinib, will treat the entire body rather than just one area, the FDA said in a statement on Monday.
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Alopecia areata, often referred to as alopecia, is an autoimmune disorder. The body attacks its own hair follicles, causing them to fall out. This usually happens in clumps, with patients losing large patches of hair at a time.
The announcement offers new hope to many who suffer from the disorder, 300,000 of whom live in the US.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research, Kendall Marcus.
Marcus added that the new treatment “will help fulfill a significant unmet need for patients with severe alopecia areata.”
Olumiant is 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. This treatment was already approved for use by the FDA in 2018 as a treatment for rheumatoid arthritis, but more recently, doctors have been using the drug to treat COVID-19 in certain hospitalized adults.
In an attempt to repurpose the drug, researchers tested Olumiant in two randomized, placebo-controlled trials (Trial AA-1 and Trial AA-2) with hundreds of patients who had at least 50 percent scalp hair loss.
Patients in these trials received either a placebo, two milligrams of Olumiant, or four milligrams of Olumiant every day. The primary measurement of efficacy for both trials was the proportion of patients who achieved at least 80 percent scalp hair coverage at week 36.
In Trial AA-1, 22 percent of the 184 patients who received two milligrams of Olumiant and 35 percent of the 281 patients who received four milligrams of Olumiant achieved adequate scalp hair coverage, compared to five percent of the 189 patients who received a placebo, the FDA said.
In Trial AA-2, 17 percent of the 156 patients who received 2 milligrams of Olumiant and 32 percent of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3 percent of the 156 patients who received a placebo.
However, the treatment comes with side effects, some of which include upper respiratory tract infections, acne, high cholesterol, and headaches. Patients could also experience nausea, anemia, weight increase, shingles, and inflammation of hair follicles.
The FDA does not recommend the treatment to be used in conjunction with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants.
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