Until recently, people suffering from alopecia areata, a disorder that causes hair loss, had no treatment that would make their hair grow back, however, the U.S. Food and Drug Administration The FDA has just approved a drug for alopecia that promises to end such suffering for adult patients.
Getting into the shower and seeing hundreds of hairs slipping through your fingers as you rub your hair is one of the most painful moments for the more than 300,000 people in the United States who are affected by this condition every year, a disorder that causes deep depression among those who have it.
The FDA has approved Eli Lilly’s Olumiant oral tablets — baricitinib — to treat adult patients with severe alopecia areata. The move marks the agency’s first approval of a systemic treatment — that is, it treats the entire body rather than a specific location — for the condition.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research.
Alopecia areata, commonly known simply as alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps.
Olumiant is a Janus kinase (JAK) inhibitor that blocks the activity of one or more enzymes from a specific family, interfering with the pathway that leads to inflammation.
The efficacy and safety of Olumiant in alopecia areata was studied in two randomized, double-blind, placebo-controlled trials in patients who had at least 50 percent scalp hair loss as measured by the Alopecia Tool severity score for more than six months.
Patients in these trials received either placebo, 2 milligrams of Olumiant, or 4 milligrams of Olumiant every day. The primary efficacy measure for both trials was the proportion of patients who achieved at least 80 percent hair coverage at week 36 (9 months).
While the drug has drawn tears and applause from patients, the most common side effects associated with Olumiant include: upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increased levels of an enzyme called creatine phosphokinase, urinary tract infection, and increased liver enzymes.
Such as inflammation of the hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital candidiasis (Candida infections), anemia, low numbers of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster), and weight gain.
Olumiant is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants.
Olumiant comes with warnings and precautions that include the recommendation of close monitoring for the development of signs and symptoms of infection during and after treatment; evaluation of patients for active tuberculosis infection and testing for latent tuberculosis prior to treatment with Olumiant; and the potential for viral reactivation.
Additionally, other warnings and precautions include hypersensitivity (allergic reactions), gastrointestinal perforations (tears in the stomach or intestine), and laboratory abnormalities including low white and red blood cell counts, elevated liver enzymes, and elevated lipids.
Olumiant comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis.
The drug was originally approved in 2018 and has also been recommended as a treatment for certain adult patients with moderately to severely active rheumatoid arthritis, as well as being approved for the treatment of COVID-19 in certain hospitalized adults.
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