FDA Says it Has Approved First ‘Systematic’ Treatment For Hair Loss Disorder, Alopecia

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06/14/2022

Photo: Joel Bissell | MLive.com

PennLive.com

The U.S. Food and Drug Administration has approved a treatment for adults with the hair loss diagnosis of alopecia areata.

Eli Lilly and Company was given the go-ahead to market Olumiant oral tablets to treat the disorder that causes patchy baldness and affects more than 300,000 people in the U.S. each year, according to the FDA.

Alopecia can cause a total loss of body hair, including eyelashes and eyebrows.

Alopecia was in the news in March when, during the Oscars, actor Will Smith walked onto the stage and slapped comedian Chris Rock after he made a joke about Smith’s wife’s baldness. Jada Pinkett Smith has dealt with alopecia for many years. Rock’s joke referred to Pinkett Smith and the movie “G.I. Jane.”

In “G.I. Jane,” actress Demi Moore appears with a shaved head.

The FDA said the new drug is the first approval “of a systemic treatment (i.e. treats the entire body rather than a specific location) for alopecia areata.”

“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 fulfill a significant unmet need for patients with severe alopecia areata.”

Olumiant was originally approved in 2018 as a treatment for severe rheumatoid arthritis. The FDA said, Olumiant is also approved for the treatment of COVID-19 in certain hospitalized adults.

Alopecia areata, commonly referred to as just alopecia, is an autoimmune disorder in which the body attacks its own hair follicles, causing hair to fall out, often in clumps, the FDA said.

In clinical trials, the FDA said patients achieved at least 80% scalp hair coverage at 36 weeks. The drug 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.”

The FDA said side effects include “upper respiratory tract infections, headache, acne, high cholesterol, 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), anemia, low number of certain types of white blood cells (neutropenia), abdominal pain, shingles (herpes zoster) and weight increase.”

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