FDA approves Olumiant for pediatric patients 12 years of age and older with severe alopecia areata – Eli Lilly

Eli Lilly and Company announced that the FDA approved Olumiant (baricitinib), a once-daily pill, for the treatment of pediatric patients 12 years of age and older with severe alopecia areata (AA).

The approval expands Olumiant’s U.S. label, building on its established use in adults with moderately to severely active rheumatoid arthritis and severe AA. AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2% of people develop AA at some point in their lives, and nearly 40% of cases occur before the age of 20. Early-onset AA can be more severe and lead to extensive hair loss.

“Today’s approval marks an important milestone for young people living with severe alopecia areata and their families, who have had limited treatment options to date,” said Adrienne Brown, executive vice president and president, Lilly Immunology. “The visible and often extensive hair loss that comes with severe alopecia areata can have a profound impact on anyone, especially adolescents who are at a pivotal stage of life. Expanding Olumiant to patients as young as 12 provides them a much-needed treatment choice and reinforces our commitment to advancing care for people living with immune-mediated diseases.”

The FDA approval is based on 36-week data from the adolescent cohort (ages 12 to under 18) of BRAVE-AA-PEDS, the first and largest Phase 3 study specifically designed to evaluate pediatric patients with severe AA. At baseline, the median Severity of Alopecia Tool (SALT) score was 100, indicating complete scalp hair loss, and patients had been living with AA for a mean of 6.4 years.

At Week 36, treatment with once-daily Olumiant delivered:

i) 80% or more scalp hair coverage, as measured by a SALT score ≤20, in 42% of patients treated with Olumiant 4 mg and 27% treated with Olumiant 2 mg, compared with 5% receiving placebo.

ii) 90% or more scalp hair coverage, as measured by a SALT score ≤10, in 37% of patients treated with Olumiant 4 mg and 21% treated with Olumiant 2 mg, compared with 2% receiving placebo.

iii) Improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4 mg.

The overall safety profile observed in pediatric patients 12 years of age and older with severe AA is consistent with the safety profile in adults with severe AA. The FDA-approved labeling for Olumiant includes a boxed warning for risk of serious infections, mortality, malignancy, major adverse cardiovascular events (MACE) and thrombosis.

“Severe alopecia areata that starts early in life can be more extensive and harder to treat over time, making it important to consider all available treatment options early in the course of disease,” said Brittany Craiglow, M.D., adjunct associate professor of dermatology, Yale School of Medicine. “The evidence supporting Olumiant’s approval is particularly meaningful because it comes from a Phase 3 study specifically designed for pediatric patients, helping clinicians and families make more informed decisions when considering advanced therapies.”

About BRAVE-AA-PEDS
BRAVE-AA-PEDS (NCT05723198) is an ongoing, placebo-controlled, Phase 3 clinical trial involving pediatric patients ages 12 to under 18 years with severe AA, as measured by a SALT score of ≥50 (i.e., who had ≥50% scalp hair loss) and a current episode of severe AA lasting at least six months but no more than eight years. The first two cohorts of patients enrolled in BRAVE-AA-PEDS included adolescents (ages 12 to under 18 years, weighing ≥ 30 kg). The first cohort included 257 adolescent participants who were randomized in a 1:1:1 ratio to receive once-daily placebo, Olumiant 4 mg or Olumiant 2 mg. The primary endpoint of this study was a SALT score ≤20 (i.e., 80% or more scalp hair coverage) at Week 36. The second cohort of 166 adolescents was randomized 1:1 to Olumiant 4 mg or Olumiant 2 mg to further accumulate safety data.