FDA Clears Fast Track for Angiogenic Gene Therapy Drug Development
July 18, 2008 - Cardium Therapeutics announced that the FDA has given it clearance for fast track designation to its lead product candidate, Generx (alferminogene tadenovec, Ad5FGF-4), designed to treat myocardial ischemia.
Generx promotes angiogenesis following a one-time intracoronary administration from a standard cardiac infusion catheter. The fast track program is designed to facilitate the development and expedite the review of new drug and biologic products that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast track designation allows a company to submit portions of a biologic license application (BLA) on a rolling basis, allowing the FDA to review sections of the BLA prior to receiving the complete application.
For more information: www.cardiumthx.com