Eli Lilly Nabs FDA Approval For First-Ever Systemic Treatment Targeting Alopecia Areata

The FDA announced on June 13 that it approved Eli Lilly’s OLUMIANT, marking it as the first systemic treatment (it treats the entire body) targeting alopecia areata (AA). The once-daily pill can potentially serve nearly 7 million people diagnosed with AA in America. This most recent approval is OLUMIANT’s second FDA approval behind use for rheumatoid arthritis and follows a recent Emergency Use Authorization (EUA) of the drug to treat COVID-19. 

OLUMIANT’s Effect On Alopecia Areata

AA is an autoimmune disorder where the body attacks its hair follicles resulting in patchy hair loss. OLUMIANT is a Janus kinase (JAK) inhibitor meaning it blocks a certain family of enzymes and interferes with the pathway to inflammation. 

According to the American Academy of Dermatology Association, other treatments for AA include topical or injection corticosteroids, which act as an anti-inflammatory, or minoxidil (Johnson & Johnson’s Rogaine), which stimulates hair growth.These options only work for some people with AA depending on their severity and are not always permanent solutions. 

The FDA based the approval of OLUMIANT for AA on two of Eli Lilly’s AA-focused clinical trials. The BRAVE-AA1 trial includes 764 participants, and the BRAVE-AA2 study consists of 546 participants studying the efficacy of OLUMIANT and the effect of different dosages on participants. Thirty-six weeks into the study, 17-22% of patients taking 2-mg/day and 32-35% of patients taking 4-mg/day saw 80% or more scalp coverage compared to 3-5% taking a placebo. On top of that, 11-13% of patients taking 2-mg/day and 24-26% of patients taking 4-mg/day achieved 90% scalp coverage, compared to 1-4% taking a placebo.

The safety profile of OLUMIANT appears very tolerable, with less than 1% of participants reporting adverse effects. Still, the FDA and Eli Lilly warn not to take OLUMIANT with other JAK inhibitors, biologic immunomodulators, cyclosporine, or other potent immunosuppressants. 

Related Article: AbbVie & Cugene Join Forces to Tackle Autoimmune Diseases

Other Uses For OLUMIANT

Despite the FDA posting warnings about JAK inhibitor’s heart disease risks, OLUMIANT continues to see success in several indications. 

In June 2018, the FDA approved OLUMIANT for rheumatoid arthritis for its anti-inflammatory properties. Clinical studies showed the drug’s efficacy, but Eli Lilly stated that it would continue to work with regulatory authorities to monitor its long-term safety. 

More recently, the FDA granted Emergency Use Authorization to OLUMIANT to treat hospitalized COVID-19 patients requiring supplemental oxygen. The May 10 announcement states that OLUMIANT used to treat COVID-19 is only permitted within hospitals. The FDA based the EUA on two clinical trials showing a substantially lower death rate among those receiving OLUMIANT compared to a placebo. 

The momentum behind OLUMiANT continues to grow, and the most recent indication targeting AA keeps the JAK inhibitor in the spotlight where researchers and regulatory authorities can keep an eye on the safety and potentially other indications in the future.

Author

Reed Slater