Indianapolis-based Eli Lilly and Co. (NYSE: LLY) and Incyte (Nasdaq: INCY) announced this week that the U.S. Food and Drug Administration has approved OLUMIANT as a treatment for adults with severe alopecia areata. The approval was based on Lilly’s BRAVE-AA1 and BRAVE-AA2 trials, which the company says is the largest Phase 3 alopecia areata clinical trial program completed to date.
The trials evaluated the efficacy and safety of OLUMIANT in 1,200 adult patients with severe alopecia areata.
“People with alopecia areata, dermatologists and other healthcare providers have been looking forward to this day when there is an FDA-approved systemic medicine for this often-devastating disease,” said Dr. Brett King, associate professor of dermatology at Yale School of Medicine and lead investigator of the BRAVE-AA program. “The results of clinical trials are remarkable, as one in five adults taking OLUMIANT 2-mg/day and one in three taking OLUMIANT 4-mg/day achieved significant hair regrowth resulting in 80% or more scalp coverage, and eyebrow and eyelash improvements were also achieved for patients taking OLUMIANT 4-mg/day with substantial eyebrow or eyelash hair loss.”
Lilly says at 36 weeks, trials showed 17-22% of patients taking OLUMIANT 2mg, and 32-35% of patients taking OLUMIANT 4mg, achieved 80% or more scalp hair coverage, compared to 3-5% taking placebo.
“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,” said Nicole Friedland, president and chief executive officer of the National Alopecia Areata Foundation. “The approval of OLUMIANT can spark hope for many patients and encourage new treatment conversations with their doctors.”
Lilly says it also expects regulatory decisions for OLUMIANT in the European Union and Japan later this year.