US FDA grants Fast Track designation to Angionetics’ Generx coronary heart disease gene therapy


The US Food and Drug Administration (FDA) has granted Angionetics “Fast Track” designation for the phase three clinical investigation of Generx [Ad5FGF-4] cardiovascular angiogenic gene therapy as a one-time treatment for improving exercise tolerance in patients who have angina that is refractory to standard medical therapy, and not amenable to conventional revascularisation procedures.

Under the FDA Modernization Act of 1997, designation as a Fast Track product means that FDA will take actions, as appropriate, to expedite the development and review of a biologics license application for product approval.

According to a company release, the FDA’s Fast Track process is designed to facilitate clinical and commercial development and expedite the review of new drugs and biologics that are intended to treat serious conditions that demonstrate the potential to address an unmet medical need.