InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology reported that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the New Drug Application (J-NDA) submitted by Shionogi & Co Ltd to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
Pirfenidone was developed in Japan for the treatment of IPF by Shionogi, which has rights to pirfenidone in Japan, Taiwan and South Korea. Dan Welch, chairman, chief executive officer and president of InterMune, said, "We are very encouraged by the Japanese regulatory approval of pirfenidone for IPF, making pirfenidone the first medicine approved for IPF patients in any major market in the world."
InterMune also provided a progress report on its phase-3 capacity programme of pirfenidone in IPF. Capacity consists of two multinational, randomized, double-blind, placebo-controlled phase-3 studies with a total enrolment of 779 IPF patients at 110 centers in the United States, Europe and Australia. The primary endpoint in capacity is change in Forced Vital Capacity (FVC) from baseline to week 72. InterMune reported that 97 percent of transplant-free, surviving patients had completed their Week 72 Visit, the study visit at which the primary endpoint is assessed.
The capacity protocol calls for a final patient visit to be completed 30 days after the Week 72 Visit. This means that all patient visits for capacity are expected to be completed around the end of October 2008. Based on this timeline for study completion, InterMune expects to announce top-line efficacy and safety results in January or February of 2009, and remains on track for submission of a New Drug Application (NDA) in mid-2009, pending positive data from capacity.
Pirfenidone has received Fast Track designation from the FDA, and if granted Priority Review status, InterMune could receive a six-month review of its NDA submission. Welch added, "As we approach the last patient visits in our two capacity studies, we are extremely pleased with the quality of the study conduct and to have exceeded our aggressive goal for having at least 95 per cent of transplant-free, surviving patients reporting for their Week 72 Visit. We look forward to reporting top-line results of capacity in January or in February of 2009."
Pirfenidone has been granted Orphan Drug and Fast Track designation in the United States and Orphan Drug designation in Europe for the treatment of IPF.