InterMune/Shionogi get Japanese IPF appro

US drugmaker InterMune says the Japanese Ministry of Health, Labor and Welfare has approved Shionogi's New Drug Application to market its pirfenidone treatment for idiopathic pulmonary fibrosis.

IPF is an ultimately fatal disease with no currently-approved treatment, that affects around 200,000 people in the USA and Europe, and is characterized by fibrosis of the lungs, hindering the ability to process oxygen and causing dyspnea and cough. The median survival time from diagnosis is two to five years. Pirfenidone has been granted Orphan Drug and Fast Track designation in the USA and Orphan Drug designation in Europe. Phase II/ III data suggest that pirfenidone may positively affect lung function and disease progression in IPF.

InterMune also provided a progress report on its two 779-patient, multinational, randomized, double-blind, placebo-controlled, Phase III CAPACITY trials of the agent in IPF. The firm reports that 97% of transplant-free, surviving patients had completed the trial.