On Monday, the Food and Drug Administration authorized baricitinib as the first oral tablet for treating severe alopecia areata, an autoimmune condition that affects over 300,000 people in the United States each year.
Alopecia areata is a condition that causes temporary or permanent patchy hair loss in any hair-bearing part of the body, causing emotional discomfort. High-profile examples including Hollywood actress Jada Pinkett Smith and congressman Ayanna Pressley have brought the issue to light recently.
"Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia," FDA official Kendall Marcus said in a statement.
"Today's approval will help fulfill a significant unmet need for patients with severe alopecia areata."
Baricitinib, marketed as Olumiant by Eli Lilly in the United States, belongs to a family of medications known as Janus kinase inhibitors. It operates by interfering with the inflammation-causing biological mechanism.
The findings of two randomized, controlled clinical studies involving a total of 1,200 people with severe alopecia led to its clearance for treatment against alopecia areata.
A placebo group, a group that got a 2-milligram dosage every day, and a group that received a 4-milligram dose every day were all assigned to each experiment.
After 36 weeks, over 40% of individuals on the higher dose had regrown 80% of their scalp hair, compared to roughly 23% of those on the lower dose and 5% of those on the placebo.
Around 45 percent of participants in the higher dosage group had substantial regeneration of their eyebrows and eyelashes.
Upper respiratory tract infections, headaches, acne, elevated cholesterol, and a rise in an enzyme called creatine phosphokinase were the most prevalent adverse effects.
Topical and oral medicines have been used in the past to treat alopecia areata, but they have all been considered experimental and none have been approved.
Baricitinib was originally licensed for the treatment of rheumatoid arthritis, and its license was extended during the COVID-19 pandemic to include the treatment of COVID-19 patients who were hospitalized.
