Eli Lilly's Olumiant snags biopharma's first FDA green light for alopecia areata

Eli Lilly’s commitment to the immunology field has paid off with another important approval for JAK inhibitor Olumiant. And it's an industry first in alopecia areata.

Alopecia, which made its way into the national conversation after the Will Smith Oscar slap, is an autoimmune disorder that causes the body to attack its own hair follicles, resulting in hair falling out. Olumiant blocks the activity of enzymes and the pathway that causes inflammation. In trials, patients who had at least 50% scalp hair loss for more than six months achieved at least 80% scalp hair coverage by Week 36 of treatment.

The drug won its original approval 2018 for severely active rheumatoid arthritis and recently picked up a new indication for COVID-19 treatment in certain hospitalized adults. Lilly filed for the alopecia indication at the end of 2021.

Despite the recent safety scrutiny on JAK inhibitors, the unmet need in the new indication gives the company hope for the drug. Current treatment is largely cosmetic, such as wigs and false eyelashes. Another option has been off-label therapies such as corticosteroid injections in the scalp.

In a recent interview, Eli Lilly's immunology president Patrik Jonsson said alopecia areata “fits very well into our current infrastructure,”

“We have the expertise in dermatology both development-wise … and also from a customer-facing perspective,” he explained.

Approximately 147 million people worldwide have or will have alopecia, with between 700,000 to 900,000 suffering from severe disease, Lilly estimates.