The FDA has approved the once-daily pill baricitinib – for the treatment of severe alopecia areata (AA) – in patients aged 12 and older, reports Medscape.
The approval extends the use of baricitinib (Olumiant, Eli Lilly), a JAK inhibitor, to younger patients, after it was initially approved for adults with moderate-to-severe rheumatoid arthritis in 2018 and subsequently approved for adults with severe AA in 2022. It also was approved in 2022 to treat Covid in certain hospitalised adults.
The new approval is based on 36-week data from patients with severe AA aged 12-17 in the BRAVE-AA-PEDS phase 3 study, according to Lilly. In the ongoing study, individuals were randomised to 2 mg or 4 mg of oral baricitinib daily or a placebo.
The primary outcome was a Severity of Alopecia Tool (SALT) score of 20 or less on a scale of 100, representing scalp hair coverage of at least 80%, after 36 weeks of treatment. At baseline, median SALT score was 100 (complete hair loss), and patients had had AA for a mean of 6.4 years.
At week 36, 42% of patients who received 4 mg and 27% of those who received 2 mg met the primary endpoint, compared with 5% of those on placebo. In addition, 37% and 21% of patients in the 4-mg and 2-mg groups, respectively, achieved SALT scores of 10 or less, representing at least 90% of scalp hair coverage, compared to 2% of those on placebo.
Patients with significant eyebrow and eyelash hair loss at baseline who received 4 mg of baricitinib showed improvement in hair coverage in these areas after 36 weeks.
Safety data for adolescent patients were similar to the data reported in adults. The FDA’s labelling for baricitinib continues to include a boxed warning for increased risk for serious infections, mortality, malignancy, major adverse cardiovascular events, and thrombosis.
The BRAVE-AA-PEDS study is currently recruiting patients aged six to 17 with severe AA.
Baricitinib is approved for treating severe AA in patients 12 and older in the European Union and Japan.
Medscape article – JAK Inhibitor for Alopecia Gets FDA Nod for Younger Age Group (Open access)
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JAK inhibitor boosts hair regrowth for severe alopecia areata – US trials
Greenlight for alopecia drug after trial results