Pirfenidone, an orally active, anti-fibrotic agent, is an investigational therapy in the US and has not been approved by the US Food and Drug Administration (FDA).
It inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions including proliferation and differentiation, and plays a major role in fibrosis.
The company said that expanded access programs provide a mechanism for early access to an investigational drug in the pre-approval period to treat patients with a serious or immediately life-threatening disease or condition that has no comparable or satisfactory alternative treatment options.
InterMune executive vice president of Research and Development Jonathan Leff said, "This EAP provides a mechanism for eligible patients to access pirfenidone as a treatment option, following the recent successful completion of our ASCEND Phase 3 trial and prior to FDA’s final decision on the approvability of pirfenidone in the United States."
In order to get enrolled in the EAP, a patient must meet specific clinical criteria of having a clinical and radiographic diagnosis of IPF with the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT).
Currently, there are a limited number of sites accepting patients for enrollment to the pirfenidone EAP and the company expects that all sites will be participating by September of 2014.
The company is working with the Pulmonary Fibrosis Foundation (PFF), the Coalition for Pulmonary Fibrosis (CPF) and other advocacy groups to allow patients with IPF to obtain information about the pirfenidone EAP.