The Food and Drug Administration on Monday approved the first systemic treatment for alopecia areata, an autoimmune disorder that causes hair loss and affects more than 300,000 people in the U.S. each year.
The drug is sold by Eli Lilly & Co. and Incyte Corp. under the brand name Olumiant and comes in the form of oral tablets taken once daily. It’s approved for adult patients with severe alopecia. In two big trials, about 40% of people with severe alopecia achieved significant hair growth after 36 weeks, according to the FDA.
“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, said in a statement. “Today’s approval will help fulfill a significant unmet need for patients.”
Olumiant was first approved in 2018 to treat adults with moderate to severe rheumatoid arthritis. Last month, it was also approved for the treatment of COVID-19 in hospitalized adults who need supplemental oxygen or who are on a ventilator.
The treatment works by blocking specific enzymes, which interferes with the pathway that leads to inflammation and can help calm down an overactive immune system. Olumiant isn’t recommended for use in combination with other immunosuppressant drugs and common side effects can include upper respiratory tract infections, headache, acne, high cholesterol and some other medical conditions.
“There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved systemic medicine,” Patrik Jonsson, Lilly’s senior vice president for immunology, said in a statement. “Our mission is to make life better for people living with debilitating immune-mediated diseases. Olumiant’s approval is a historic moment.”
Alopecia was the subject of national attention back in March, when actor Will Smith slapped Chris Rock on stage at the Oscars after the comedian made a joke about his wife Jada Pinkett Smith’s short hair. The actress and host of “Red Table Talk” has been vocal about her struggle with alopecia, during one 2018 episode revealing that it was “terrifying” when the hair loss first started.
“I was in the shower one day and then just handfuls of hair just in my hands,” Pinkett Smith said at the time. “It was one of those times in my life that I was literally shaking with fear.”
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