Corautus gets US fast track status angina gene therapy :
This article was originally published in Clinica
Executive Summary
The US FDA has designated Corautus Genetics' gene therapy treatment for severe angina fast track status, a classification designed to help companies accelerate a product's development to commercialisation. The vascular endothelial growth factor 2 (VEGF-2) treatment, which is being developed in collaboration with Boston Scientific, is intended to promote therapeutic angiogenesis in ischaemic muscle; trials are underway to assess VEGF-2 delivered percutaneously via Boston's Stiletto endocardial direct injection catheter system. Fast track-designated products are eligible for priority review - six months versus the average 12 months - and/or the review of portions of the marketing application prior to the completion of the final registration package.