Posted by Michael Wonder on 14 Aug 2019
Akari Therapeutics receives FDA fast track designation for nomacopan for paediatric haematopoietic stem cell transplant-related thrombotic microangiopathy
14 August 2019 - Proposed pivotal trial of nomacopan in paediatric patients with HSCT-TMA expected to start Q4 2019 in North America and Europe.
Akari Therapeutics today announced that the U.S. FDA has granted fast track designation for nomacopan for the treatment of haematopoietic stem cell transplant associated thrombotic microangiopathy (HSCT-TMA) in paediatric patients.
The fast track designation supports Akari’s plans for expedited approval of nomacopan for HSCT-TMA, with the pivotal trial expected to commence in the fourth quarter of 2019.
