The US Food and Drug Administration (FDA) has approved the drug baricitinib to treat gyroid alopecia, an autoimmune disorder that affects more than 147 million people each year worldwide. Alopecia is generally referred to as hair loss in parts of the body that usually have hair.
“Access to safe and effective treatment options is vital for a significant number of Americans suffering from severe alopecia,” said FDA official Kendall Markus.
Baricitinib, manufactured by the American drug company Eli Lilly, belongs to a class of drugs known as JAK inhibitors and works by interfering with the cellular pathway that leads to inflammation.
Its approval for use against alopecia was based on the results of two randomized, controlled clinical trials involving a total of 1,200 adults with severe alopecia.
Patients were divided into three groups and received either 2 or 4 mg of the drug or placebo daily. After 36 weeks, almost 40% of the patients receiving the highest dose achieved 80% coverage of the scalp with hair growth compared with 23% of the group receiving the lowest dose and 5% of the group receiving the placebo. About 45% of people in the higher dose group also saw significant regeneration of their eyebrows and eyelashes.
The most common side effects included upper respiratory tract infections, headaches, acne, high cholesterol, and an increase in an enzyme called creatine phosphokinase.
Baricitinib had previously been approved for the treatment of rheumatoid arthritis, and during the coronavirus pandemic its authorization was extended to the treatment of patients treated with COVID-19.
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SOURCE: Medicalxpress, ERT