Akari Therapeutics Receives FDA Fast Track Designation for Nomacopan for Pediatric Hematopoietic Stem Cell Transplant-Related Thrombotic Microangiopathy (HSCT-TMA)
Akari Therapeutics Plc - American Depositary Shares (AKTX)
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Source: GlobeNewswire
Fast Track designation by the U.S. Food and Drug Administration (FDA) facilitates the development and expedites the review of new medicines like nomacopan that treat serious unmet medical needs and in Akari’s case, pediatric patients with HSCT-TMA. The Fast Track designation follows a successful pre-investigational new drug (IND) FDA meeting earlier this year regarding Akari’s proposed pivotal clinical trial program for HSCT-TMA. The FDA is working with Akari in its optimization of pediatric dosing for HSCT-TMA by Akari’s participation in the FDA Model-Informed Drug Development (MIDD) Program with supportive PK data provided by pediatric patients already treated with nomacopan as part of a named patient program. Proposed pivotal trial of nomacopan in pediatric patients with HSCT-TMA expected to start Q4 2019 in North America and Europe. NEW YORK and LONDON, Aug. 14, 2019 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative t
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