The FDA has followed highly promising results from trials demonstrating the hair regrowth potential of a common arthritis drug with a landmark approval, giving baricitinib the green light as a treatment for severe alopecia areata. The move makes the drug the first ever FDA-approved drug for systemic treatment of the disease, and will take the form of a daily pill that proved hugely promising in recent Phase 3 trials.
Baricitinib is a drug originally developed to treat rheumatoid arthritis, and recently began to attract interest from scientists researching treatments for another autoimmune disorder in the form of alopecia areata. This condition affects more than 300,000 people in the US every year, and causes patchy hair loss through immune system attacks on the hair follicles. Prior to today, there were no FDA-approved treatments for the condition.
Scientists began to investigate baricitinib's potential to tackle alopecia areata based on the idea that it could interrupt the signaling pathways that harm hair follicles. Results published in March from Phase 3 trials involving around 1,200 people with the condition showed that around one third of them were able to regrow their hair by taking four-milligram pills of baricitinib each day. Two-milligram doses, meanwhile, also brought improvements in scalp hair coverage in almost a fifth of patients.