Legacy Healthcare Receives Positive Feedback from Japan’s Health Authority (PMDA) on Regulatory Pathway and Phase 3 Clinical Program for Cinainu in Japanese Children, Adolescents and Adults with Moderate to Severe Alopecia Areata (AA)
— In a European Phase 2/3 trial,Cinainu cutaneous solution was demonstrated to promote hair regrowth, improve quality of life and showed sustained effect after treatment discontinuation; Cinainu was well-tolerated, with no immunosuppression-related adverse events; the trial did not include Japanese subjects, — In an end-of-Phase 2 meeting, the PMDA informed Legacy Healthcare that a single […]