The U.S. Food and Drug Administration (FDA) has approved the drug Olumiant (baricitinib) for adult patients with severe alopecia areata, an immune disorder that often results in hair loss. The medicine is the first FDA approval of a systemic or full-body drug for the condition, per a statement.
The drug was originally developed by the pharmaceutical company Eli Lilly and has already been on the market for about four years for treating rheumatoid arthritis and other autoimmune diseases. Oluminant was studied in two trials for the treatment of alopecia areata, and the results were published last month in the New England Journal of Medicine.
Alopecia areata is a disease that occurs when the immune system attacks hair follicles, causing hair loss. Hair loss is usually found on the head and face but can occur in small, round, coin-shaped patches anywhere on the body, according to the National Institutes of Health. About 700,000 individuals in the United States are living with alopecia areata. Roughly 40 percent of those individuals have a severe form of the autoimmune disorder, meaning that they are missing at least half of the hair on their scalp, STAT reports.
Until now, no approved treatment existed to make hair grow back in patients with alopecia areata. Those with the disorder had to rely on unapproved creams, cosmetic solutions and injections to manage their condition, Jonathan Wosen and Akila Muthukumar report for STAT. "Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA's Center for Drug Evaluation and Research, says in a statement. "Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."
Eli Lilly's drug prevents the immune system from attacking hair follicles. Pharmaceutical companies like Pfizer and Concert Pharmaceuticals are working on similar drugs to Oluminant.
The phase III trials for Eli Lilly's drug involved 1,200 patients with severe alopecia areata. Study participants either took a daily pill containing two milligrams or four-milligrams of the drug, or a placebo containing no medication. Almost 40 percent of individuals who took the higher drug dose had complete or near-complete hair regrowth after 36 weeks, and after a year, nearly half of patients had their hair back, reports the New York Times. Patients who received the drug also reported regrowth of hair along their eyelashes and eyebrows.
Mild side effects were reported and included an increased risk for acne, urinary tract infections, headaches, high cholesterol and other infections. The drug’s list price is $2,500 for a one-month supply of the two milligram dose. But, Patrik Jonsson, Eli Lilly's president of immunology, told STAT that the company is dedicated to making sure out-of-pocket costs for the drug are as little as $5 a month for insured individuals and $25 for those who are uninsured.