The oral medication, called barnicitinib and marketed as Olumiant, has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of alopecia areata in adults.
The Food and Drug Administration (FDA) has approved the first oral drug that restores hair growth in patients with alopecia areata, an autoimmune disease that can affect one or more parts of the body, including the scalp, face, trunk and extremities, causing It causes hair and hair to appear. Hair loss, often in the form of spots. The disease, estimated to affect 0.2% of people regardless of gender and race in the world, can occur at any age and has recently made headlines with cases of well-known figures to the general public, including actress Jada Pinkett, wife of Will Smith. ” Access to safe and effective treatment options is essential for the large number of Americans with severe alopecia areata – said Kendall Marcus, an FDA official. Today’s approval will help address a huge unmet need for alopecia areata patients“.
The drug, made by US drugmaker Eli Lilly, will be marketed as Olumiant (baricitinib) and belongs to a class of drugs called Janus kinase (JAK) inhibitors that work by interfering with the cell signaling pathway that leads to inflammation. The drug, which is already approved for the treatment of rheumatoid arthritis and for the treatment of severe forms of Covid-19 in hospitalized adult patients, has proven effective in restoring hair growth in alopecia areata patients, as two randomized controlled trials have shown. with placebo, which was promoted by Eli Lilly and published last month in New England Journal of MedicineIncludes 1200 patients suffering from severe hair loss.
Patients in the Eli Lilly clinical trial, before and after 36 weeks of treatment with baricitinib
Nearly 40% of those who took the drug at a dose of 4 mg per day experienced complete or almost complete hair regrowth after 36 weeks, compared to 23% of the group who received the dose of 2 mg per day and 5% of the placebo group. About 45% of people in the higher dose group also reported significant growth in their eyelashes and eyebrows.
As for the side effects, the most common are upper respiratory tract infections, headaches, acne, high cholesterol (hyperlipidemia), and an increase in the enzyme creatinine phosphokinase. The drug is not recommended for use with other JAK inhibitors, biological immunosuppressants, cyclosporine or other potent immunosuppressants, and comes with warnings and precautions, including recommending close monitoring for the development of signs and symptoms of infection during and after treatment.