Olumiant is marked as the first and only systemic medicine for severe AA adult patients.
It is an oral and once-daily JAK inhibitor which is available through specialty pharmacies across the nation.
Olumiant 2-mg per day is the recommended dose for patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss.
This can be increased to 4-mg per day if the treatment response is inadequate and can be decreased to 2-mg per day once the adequate response is achieved.
The regulatory approval was based on data obtained from the BRAVE-AA1 and BRAVE-AA2 trials, which evaluated Olumiant’s efficacy and safety in 1,200 severe AA adult patients.
In the trials, 17 to 22% of the patients who are taking 2mg dose and 32 to 35% at the 4mg dose group achieved at 80% scalp hair coverage by 36 weeks of treatment.
Additionally, 24 to 26% of patients at the 4-mg and 11 to 13% at the 2-mg have achieved 90% or more hair coverage, compared to 1 to 4% of the patients taking placebo.
Lilly senior vice-president, Lilly Immunology and Lilly USA president, and chief customer officer Patrik Jonsson said: “There is a significant unmet medical need for people with alopecia areata given there has never been an FDA-approved systemic medicine.
“In fact, a study published in 2017 of 1,083 people with AA showed that nearly 80% were unsatisfied with their treatment options.
“Our mission is to make life better for people living with debilitating immune-mediated diseases. Olumiant’s approval is a historic moment, and we’re delighted about what it can mean for adults with severe alopecia areata.”
The company noted that the therapy is not recommended to be used in combination with other JAK inhibitors, cyclosporine, biologic immunomodulators, or other potent immunosuppressants.