Posted by Michael Wonder on 31 Jan 2023
Reneo Pharmaceuticals receives fast track designation from the FDA for mavodelpar (REN001) in a genotype of long-chain fatty acid oxidation disorder
31 January 2023 - Reneo Pharmaceuticals today announced that the US FDA has granted mavodelpar (REN001) fast track designation for long chain 3-hydroxyacyl-CoA dehydrogenase deficiency, one of the predominant genotypes in patients with long-chain fatty acid oxidation disorder.
The company recently completed a natural history study (FORWARD) and an open label study evaluating mavodelpar in patients with long-chain fatty acid oxidation disorder that included multiple genotypes, including the long chain 3-hydroxyacyl-CoA dehydrogenase genotype.
