Biotech company InterMune, Inc. (ITMN) said Monday that the U.S. Food and Drug Administration, or FDA granted a priority revenue designation to its New Drug Application for pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis, or IPF. The FDA also set an action date for the NDA of May 4, based on the Prescription Drug User Fee Act. Shares are trading up nearly 7% in the pre-market session, on the Nasdaq.
Priority Review designation by the FDA expedites the NDA approval process by reducing the target review period for the application from about 10 months to 6 months. It is granted for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. Pirfenidone demonstrated both anti-fibrotic and anti-inflammatory effects in preclinical and in-vitro studies.
With currently zero medicines approved in the United States or Europe, IPF is a progressive, disabling and ultimately fatal disease that affects approximately 200,000 patients in the U.S. It is characterized by inflammation and scarring in the lungs, hindering the ability to process oxygen and causing shortness of breath and cough. In the U.S. and Europe combined nearly thirty thousand new cases are reported every year.
In October 2008, pirfenidone was approved for use in IPF patients in Japan and is marketed as Pirespa by Shionogi & Co. Ltd. In the first half of fiscal 2009, Shionogi booked actual sales of 0.6 billion yen for Pirespa, and forecasts 1.1 billion yen and 1.7 billion yen for the second-half and full fiscal, respectively.
InterMune licensed pirfenidone from Marnac, Inc. and its co-licensor, KDL GmbH in 2002. This was followed by purchase of the compound's sales rights in the U.S., Europe and other territories, in 2007. However, the sales rights exclude Japan, Taiwan and South Korea, where it was licensed by Marnac and KDL to Shionogi of Japan.
"We are pleased to have begun the review process of the first NDA submitted to FDA for a medicine for IPF patients and we look forward to working with the Pulmonary-Allergy Division to complete the review as expeditiously and thoughtfully as possible," noted Dan Welch, President, Chief Executive of InterMune.
ITMN closed Friday's regular trading at $13.07, on the Nasdaq. In the pre-market session, it is up $0.96 or 7.36%.
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