The fast track development program facilitates development and expedites regulatory review of drugs intended to address an unmet medical need for serious or life-threatening conditions.
PRO 140 belongs to a new class of HIV/AIDS therapeutics – viral-entry inhibitors – that are intended to protect healthy cells from viral infection. PRO 140, currently in phase Ib clinical trials in HIV-infected individuals, is a humanized monoclonal antibody directed against CCR5, a molecular portal that HIV uses to enter cells.
“Fast track status has the potential to accelerate the development of PRO 140,” said Dr Paul Maddon, Progenics’ chief science officer. “Although great strides have been made in HIV treatment, there is an urgent need for the development of new therapies such as PRO 140 to address the limitations of currently available HIV drugs.”
With fast track designation for PRO 140, Progenics can take advantage of several programs at the FDA to streamline the regulatory review process and to work more closely with the agency on product development plans.