More than 300,000 people in the United States are affected by severe alopecia areata, which can be treated with an oral tablet.
Any hair-bearing site of the body can be affected by patchy hair loss caused by alopecia areata. Jada Pinkett Smith and Ayanna Pressley are just two of the high-profile cases that have brought about the condition.
"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," said the FDA official.
Today's approval will help fulfill a significant unmet need.
A drug called Baricitinib is made by Eli Lilly and is also known as Olumiant. The pathway that leads to inflammation is interfered with.
The approval was based on the results of two randomized, controlled clinical trials involving a total of 1,200 people with severe hair loss.
A placebo group, a group that received a 2-milligram dose every day, and a group that received a 4-milligram dose every day were all part of the trial.
Almost 40 percent of those on the higher dose grew back 80 percent of their hair, compared to 23 percent of the lower dose and 5 percent of the placebo.
More than half of the people in the higher dose group saw regrowth of their eyebrows.
The most common side effects were upper respiratory tract infections and headaches.
None of the previous treatments for Alopecia areata have been approved.
Baricitinib's license was extended to the treatment of hospitalized COVID-19 patients when it was approved for rhythym.
Agence France- Presse.
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