On Monday (June 13), the Food and Drug Administration (FDA) authorized baricitinib as the very first oral medication for effectively treating alopecia areata, an autoimmune condition that affects over 300,000 individuals in the United States each year.
Alopecia creates patchy baldness that can be momentary or permanent and can damage any hair-bearing region on the body, causing emotional discomfort. High-profile examples, such as Hollywood actress Jada Pinkett Smith & congresswoman Ayanna Pressley, have brought the issue to light lately.
In a statement, FDA representative Kendall Marcus stated that Access to effective and safe treatment strategies is critical for the considerable number of Americans impacted by severe alopecia. Topical and oral medications have been used in the past to treat alopecia, but they were regarded as experimental and none of them were authorized.
Baricitinib, marketed as Olumiant by Eli Lilly in the United States, belongs to a type of medication known as Janus kinase inhibitors. It operates by interacting with the inflammation-causing biological mechanism.
The analysis of two random, clinical studies consisting of a total of 1,200 people with severe alopecia resulted in its clearance to be used against alopecia.
A placebo unit, a unit that got a 2mg dose daily, and then a group that obtained a 4mg dose each day were all assigned to each experiment.
After 36 weeks, nearly 40% of individuals on the high dosage had regrown 80% of their head hair, equating to around 23% of those on the low dosage and 5% of those on the placebo.
Around 45 % in the higher unit experienced substantial regeneration of their eyebrows and eyelashes.
Upper respiratory tract infection, headaches, pimples, elevated cholesterol, and a rise in an enzyme known as creatine phosphokinase seem to be the most frequent side effects.
Topical and oral medications have been used in the past to treat alopecia, but they were regarded as experimental and none of them were authorized.
According to THE STRAITS TIMES, Baricitinib was originally prescribed for the treatment of rheumatoid arthritis, as well as its permission was upgraded to include the treatment of admitted Covid-19 patients during the Covid-19 pandemic.