The FDA granted Breakthrough Therapy Designation to investigational cutaneous solution CINAINU (LH-8) for alopecia areata in patients aged 2 years and older.
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The designation was supported by the phase 2/3 RAAINBOW trial, a randomized, double-blind, placebo-controlled study of 107 participants aged 2 to 17 years.
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Legacy Healthcare reported meaningful hair regrowth, favorable tolerability, and sustained benefits with LH-8, but provided no numerical efficacy or safety results.
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Breakthrough Therapy Designation is intended to accelerate development and review and does not constitute FDA approval.
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Legacy Healthcare is preparing a global pivotal phase 3 program evaluating LH-8 in adults, adolescents, and children with moderate-to-severe alopecia areata.
