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The FDA approves hair growth pill for alopecia patients




The Food and Drug Administration on Monday approved a drug to treat severe alopecia, which causes baldness in more than 300,000 Americans each year.

The approval of Olumiant (baricitinib) was remarkable because it is the first drug approved by the authorities to treat the whole body for autoimmune disorders instead of a specific site, the FDA said in a press release on Tuesday.

“Access to safe and effective treatment options is crucial to the significant number of Americans affected by severe alopecia,” said Kendall Marcus, MD, director of the Department of Dermatology and Dentistry at the FDA̵[ads1]7;s Center for Drug Evaluation and Research.

“Today’s approval will help meet a significant unmet need for patients with severe alopecia areata.”

Alopecia patients lose lumps of hair when the immune system attacks their own hair follicles. Olumiant is blocking the activity of a family of enzymes that inflame the attack, the FDA said.

In randomized trials, more than a third of patients who took 4 milligrams of the drug each day increased their head hair coverage from 50 percent to 80 percent, researchers said.

Side effects include upper respiratory tract infections, headaches, acne, high cholesterol, weight gain, shingles and urinary tract infections, among others, according to officials.

“Olumiant is also approved for the treatment of COVID-19 in certain hospitalized adults,” the publication states.

Alopecia made headlines earlier this year when Will Smith rushed to the Oscars stage to attack Chris Rock after the cartoon barred his wife Jada Pinkett Smith’s baldness, which is caused by the condition.



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