Prochymal Obtains Fast-Track Status for Acute GvHD

Osiris Therapeutics’ Prochymal has received fast-track designation from the FDA as a first-line agent for acute graft versus host disease (GvHD).

A Phase III pivotal study for this indication was started in November and is enrolling patients.

Prochymal had fast-track status for the treatment of steroid-refractory acute GvHD in 2005 and for Crohn's disease in 2006. Both programs are enrolling patients in Phase III registration trials, Osiris said.