Posted by Michael Wonder on 07 Jan 2019
FDA grants Revalesio fast track status for ALS investigational drug RNS60
4 January 2019 - Revalesio announced today that the U.S. FDA granted fast track status for its investigational drug RNS60 as a treatment for amyotrophic lateral sclerosis, also known as Lou Gehrig’s disease.
Fast Track and other expedited review programs of the FDA were designed to speed up drug development for life threatening illnesses.
Pre-clinical research has shown that RNS60 protects neurons and other supporting cells in the brain and spinal cord by enhancing mitochondrial biogenesis and ATP production. In a recently completed open label clinical study at Massachusetts General Hospital, RNS60-treated amyotrophic lateral sclerosis patients experienced a much slower than expected decline of vital capacity compared to historical controls.
