Legacy Healthcare, a biopharmaceuticalcompany developing innovative botanical prescription drugs, today announced that the U.S. Food andDrug Administration (FDA) has granted Breakthrough Therapy Designation to CINAINU® (LH-8), itsinvestigational cutaneous solution treatment for moderate-to-severe alopecia areata in adults,adolescents and children aged two years and older.
The designation was supported by the RAAINBOW Phase 2/3 trial, a randomized, double-blind,placebo-controlled study involving 107 children and adolescents aged 2–17 years.
Breakthrough Therapy Designation is intended to accelerate the development and review ofinvestigational therapies showing preliminary evidence of substantial improvement over availabletreatments.
A Broader and Potentially Better Treatment Option for Alopecia Areata patients
Today, oral Janus kinase (JAK) inhibitors are the only approved treatment option for alopecia areata.However, they are limited to adults and adolescents with severe forms of the disease. Patients withmoderate forms, who represent the majority of alopecia areata sufferers, have no approved treatment.
Children also have no approved treatment. Importantly, oral JAK inhibitor discontinuation triggers rapidhair loss, and these medicines carry FDA boxed warnings for serious safety risks, including infections,malignancy, cardiovascular events and thrombosis.
CINAINU® is being developed for both moderate and severe alopecia areata, and across all age groupsand has demonstrated in its first Phase 2/3 trial meaningful hair regrowth, combined with a favorabletolerability profile and sustained benefit. This profile could make it an attractive first-line option formoderate-to-severe alopecia areata. Subject to further clinical investigation, CINAINU® could also bepositioned as a continuation treatment after oral JAK inhibitors.
