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FDA Approves First Oral Drug For Alopecia Areata That Reverses Hair Loss Caused By Disease

United States Food and Drug Administration (FDA) approved the first systemic treatment for Alopecia, a disorder in which a person loses all hair on the scalp. 

FDA

Image: Pixabay/ Representative


United States Food and Drug Administration (FDA), on Monday, approved the first systemic treatment for Alopecia areata, a disorder in which a person loses all hair on the scalp. In a news release on June 13, US FDA said that it has approved “Olumiant (baricitinib) oral tablets to treat adult patients with severe alopecia areata” which impacts more than 300,000 people in the United States every year. FDA approved the systematic treatment which treats the entire body rather than a specific location for the disorder. 

“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfil a significant unmet need for patients with severe alopecia areata.”

What is Alopecia Areata?

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 which blocks the activity of one or more of a specific family of enzymes, interfering with the pathway that leads to inflammation, FDA said. 

FDA-approved treatment’s side-effects

The US agency noted that the “most common side effects associated with Olumiant include: upper respiratory tract infections, headache, acne, high cholesterol (hyperlipidemia), increase of an enzyme called creatinine phosphokinase,  urinary tract infection,  liver enzyme elevations, inflammation of hair follicles (folliculitis), fatigue, lower respiratory tract infections, nausea, genital yeast infections (Candida infections), anaemia, low number of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster) and weight increase.”

“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 including recommending close monitoring for the development of signs and symptoms of infection during and after treatment; evaluating patients for active tuberculosis infection and testing for latent tuberculosis prior to treatment with Olumiant; and the potential for viral reactivation...Olumiant comes with a boxed warning for serious infections, mortality, malignancy, major adverse cardiovascular events and thrombosis,” FDA noted

Image: Pixabay/ Representative

 

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