FDA Approves First Drug of Its Kind for Severe Alopecia

People with a severe form of baldness will now have a significant treatment option available. On Monday, the Food and Drug Administration approved baricitinib for treating alopecia areata. The drug, taken as a pill, is the first of its kind intended to treat the autoimmune disorder, though it’s already commonly used for other conditions like rheumatoid arthritis.

Alopecia areata is caused by an overactive immune system that attacks hair follicle cells. Hair loss typically occurs before age 40, and symptoms can range from periodically losing patches of scalp hair to the permanent loss of hair throughout the body. It’s thought to affect 7 million people in the U.S.

There is no cure for alopecia areata. Current treatments include steroids, minoxidil (the active ingredient in Rogaine and other hair growth products), and phototherapy. These treatments may be able to stimulate new hair growth in some people, but don’t necessarily prevent future hair loss, and they’re less effective for severe cases. In recent years, scientists have been studying whether an existing class of drugs known as JAK inhibitors—including baricitinib—may be able to better block the aspects of the immune system that mistakenly attack hair follicles in these individuals.

In two large phase III trials published earlier this year, patients with severe alopecia areata treated with baricitinib experienced greater hair growth than those given a placebo. In those given the highest dose, around a third regained a large degree of their hair (before-and-after images can be seen here). People on the drug did experience a greater risk of adverse events like acne, weight gain, and certain infections, which are common complications for immune-suppressing drugs. Other research has suggested that people will need to remain on these drugs to maintain their hair growth.

Baricitinib was developed by Eli Lilly and is used to treat other immune-related conditions, such as rheumatoid arthritis. It’s even been used to treat severe covid-19. Now, it’s the first specialized and systemic treatment for alopecia areata (current treatments for it are off-label and typically topical, meant to treat local hair loss, but this would be intended to treat hair loss anywhere on the body). It will continue to be sold under the brand name Olumiant.

“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, in a statement. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Though baricitinib may have been the first JAK inhibitor to be approved for alopecia areata, it’s unlikely to be the last. Clinical trials of other existing and newly developed JAK inhibitors are ongoing.

People with a severe form of baldness will now have a significant treatment option available. On Monday, the Food and Drug Administration approved baricitinib for treating alopecia areata. The drug, taken as a pill, is the first of its kind intended to treat the autoimmune disorder, though it’s already commonly used for other conditions like rheumatoid arthritis.

Alopecia areata is caused by an overactive immune system that attacks hair follicle cells. Hair loss typically occurs before age 40, and symptoms can range from periodically losing patches of scalp hair to the permanent loss of hair throughout the body. It’s thought to affect 7 million people in the U.S.

There is no cure for alopecia areata. Current treatments include steroids, minoxidil (the active ingredient in Rogaine and other hair growth products), and phototherapy. These treatments may be able to stimulate new hair growth in some people, but don’t necessarily prevent future hair loss, and they’re less effective for severe cases. In recent years, scientists have been studying whether an existing class of drugs known as JAK inhibitors—including baricitinib—may be able to better block the aspects of the immune system that mistakenly attack hair follicles in these individuals.

In two large phase III trials published earlier this year, patients with severe alopecia areata treated with baricitinib experienced greater hair growth than those given a placebo. In those given the highest dose, around a third regained a large degree of their hair (before-and-after images can be seen here). People on the drug did experience a greater risk of adverse events like acne, weight gain, and certain infections, which are common complications for immune-suppressing drugs. Other research has suggested that people will need to remain on these drugs to maintain their hair growth.

Baricitinib was developed by Eli Lilly and is used to treat other immune-related conditions, such as rheumatoid arthritis. It’s even been used to treat severe covid-19. Now, it’s the first specialized and systemic treatment for alopecia areata (current treatments for it are off-label and typically topical, meant to treat local hair loss, but this would be intended to treat hair loss anywhere on the body). It will continue to be sold under the brand name Olumiant.

“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, in a statement. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”

Though baricitinib may have been the first JAK inhibitor to be approved for alopecia areata, it’s unlikely to be the last. Clinical trials of other existing and newly developed JAK inhibitors are ongoing.