Priority Review designation may be granted by the FDA to an NDA for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. This designation has the potential to expedite the NDA approval process by reducing the target review period for the application from approximately 10 months to six months. Based on the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for the NDA of May 4, 2010.
Idiopathic pulmonary fibrosis (IPF) is a disease characterized by progressive scarring, or fibrosis, of the lungs, which leads to their deterioration and destruction. It occurs in older patients (aged 50-70 years) and has a median survival of approximately 2-5 years from diagnosis.
Pirfenidone is an orally active small molecule drug that may inhibit collagen synthesis, down regulate production of multiple cytokines and block fibroblast proliferation and stimulation in response to cytokines.
Phase II and III trials have been completed and it will be interesting to see what the FDA and it's advisory committee make of the data when they review it in a few months.