Eli Lilly and Company announced recently that the US Food and Drug Administration (FDA) has 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 US label, building on its established use in adults with moderately to severely active Rheumatoid Arthritis (RA) and severe AA.

AA is a chronic immune-mediated disease that causes unpredictable hair loss. As many as 2 percent of people develop AA at some point in their lives, and nearly 40 percent of cases occur before the age of 20. Early-onset AA can be more severe and lead to extensive hair loss.

Adrienne Brown, Executive Vice President and President, Lilly Immunology, said, "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. 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 80 percent or more scalp hair coverage, as measured by a SALT score ≤20, in 42 percent of patients treated with Olumiant 4 mg and 27 percent treated with Olumiant 2 mg, compared with 5 percent receiving placebo; 90 percent or more scalp hair coverage, as measured by a SALT score ≤10, in 37 percent of patients treated with Olumiant 4 mg and 21 percent treated with Olumiant 2 mg, compared with 2 percent receiving placebo; and improved eyebrow and eyelash coverage among patients with substantial eyebrow and eyelash hair loss at baseline treated with Olumiant 4 mg.

The Overall Safety (OS) 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.

Brittany Craiglow, MD, Adjunct Associate Professor of Dermatology, Yale School of Medicine, said, "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. 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."

Olumiant is available as 4 mg, 2 mg and 1 mg tablets. The recommended dose is Olumiant 2 mg/day, with an increase to 4 mg/day if treatment response is inadequate. For patients with nearly complete or complete scalp hair loss, with or without substantial eyelash or eyebrow hair loss, consider treating with 4 mg/day. Once an adequate response is achieved on 4 mg/day, the dosage is to be decreased to 2 mg/day.

Lilly is committed to ensuring patients have access to much-needed medicines. Today, Olumiant has coverage at 3 of the largest Pharmacy Benefit Managers (PBMs) for adults with severe AA. Through Lilly Support Services for Olumiant, Lilly offers a patient support program including co-pay assistance for eligible, commercially insured patients.

George Gondo, Chief Mission Officer, National Alopecia Areata Foundation, said, "Alopecia Areata can affect much more than hair, particularly during adolescence, when young people are navigating important personal and social milestones. More treatment choices mean more families have the opportunity to find the option that's right for their child, together with their doctor."