InterMune, a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and orphan fibrotic diseases, announced it will provide compassionate use of pirfenidone through a multi-centre Expanded Access Programme (EAP) in the United States to be conducted under InterMune's US IND. Pirfenidone is an investigational therapy in the US and has not been approved by the US Food and Drug Administration (US FDA).
Expanded access programmes 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.
"We are pleased to offer this expanded access programme for eligible patients in the US," said Jonathan Leff, managing director, executive vice president of research and development, (R&D) InterMune. "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."
To enroll in the EAP, a patient must meet specific clinical criteria. Eligible patients must have a clinical and radiographic diagnosis of IPF with the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT). Additional criteria for the EAP are listed on www.clinicaltrials.gov. It is important to note that only a physician who is participating in the EAP can assess a potential patient for eligibility. The EAP protocol contains provisions for stopping enrollment of patients in the EAP upon a decision by the FDA on the approvability of a pirfenidone New Drug Application (NDA).
There are currently a limited number of sites accepting patients for enrollment to the pirfenidone EAP and InterMune expects that all sites will be participating by September of 2014. InterMune is working with the Pulmonary Fibrosis Foundation (PFF), the Coalition for Pulmonary Fibrosis (CPF) and other advocacy groups to enable patients with IPF to obtain information about the pirfenidone EAP.