The FDA has approved baricitinib as a therapy for severe alopecia areata, following extremely positive findings from trials confirming the hair regeneration potential of a popular arthritis medicine. The medicine will now be the first FDA-approved therapy for systemic treatment of the condition, and will come in the form of a daily tablet, which has shown great promise in recent Phase 3 trials.
Baricitinib is a medicine that was initially created to treat rheumatoid arthritis, but it has lately piqued the curiosity of scientists looking for remedies for another inflammatory illness known as alopecia areata. This disorder affects over 300,000 people in the United States each year and causes patchy hair loss due to immune system assaults on hair follicles. There were no FDA-approved therapies for the illness prior to today.
Scientists began looking at baricitinib’s potential to treat alopecia areata on the basis that it might disrupt the signalling pathways that damage hair follicles. Results from Phase 3 studies involving over 1,200 persons with the disease published in March revealed that almost one-third of them were able to regrow their hair by taking four-milligram capsules of baricitinib each day. Meanwhile, two-milligram dosages improved scalp hair covering in nearly a fifth of individuals.
Approval to first systematic treatment of Alopecia
The medicine, which will be offered under the brand name Olumiant by pharmaceutical giant Eli Lilly, has now met the FDA’s safety and effectiveness standards, allowing the agency to approve it as the first in-disease systemic therapy for alopecia areata. That is, the medicine will be accessible in 1-, 2-, and 4-milligram daily dosages based on treatment response, rather than particular sites.
“Today marks a milestone with the first-ever FDA-approved systemic treatment for alopecia areata patients, who face significant challenges every day, including limited public knowledge about the disease, a lack of treatment options and social stigma,” a daily quoted Nicole Friedland, president and chief executive officer, National Alopecia Areata Foundation (NAAF). “The approval of Olumiant can spark hope for many patients and encourage new treatment conversations with their doctors. NAAF wants more choices for our patient community and with the approval of Olumiant, there are now new treatment expectations being established in alopecia areata care.”
Olumiant is a JAK inhibitor that operates by inhibiting the activity of one or more enzyme families. It should not be used with other JAK inhibitors. Common side effects include respiratory tract infections, headaches, acne, and weight gain, and it’s worth mentioning that 2.2 percent of individuals dropped out of the clinical trial programme owing to unpleasant occurrences.
“Access to safe and effective treatment options is crucial for the significant number of Americans affected by severe alopecia,” said Kendall Marcus, M.D., director of the Division of Dermatology and Dentistry in the FDA’s Center for Drug Evaluation and Research. “Today’s approval will help fulfill a significant unmet need for patients with severe alopecia areata.”
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