Biopharmaceutical company Legacy Healthcare announced on Tuesday that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to CINAINU (LH-8), its investigational cutaneous solution treatment for moderate-to-severe alopecia areata in adults, adolescents and children aged 2 years and older.
This designation was supported by the RAAINBOW Phase 2/3 trial, a randomised, double-blind, placebo-controlled study involving 107 children and adolescents aged 2-17 years.
CINAINU is being developed for both moderate and severe alopecia areata, and across all age groups. In its first Phase 2/3 trial it demonstrated hair regrowth, combined with a favourable tolerability profile and sustained benefit. This profile could make it an attractive first-line option for moderate-to-severe alopecia areata.
Subject to further clinical investigation, CINAINU could also be positioned as a continuation treatment after oral JAK inhibitors.
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