On Monday, InterMune, the biotech firm, confirmed that the US Food and Drug Administration has granted a priority review status to its New Drug Application for pirfenidone, the company's treatment drug for patients suffering from idiopathic pulmonary fibrosis, or IPF.

Also, May 4 has been set as the action date for the NDA, on the basis of the Prescription Drug User Fee Act.

Priority Review has been designed by the FDA in order to speed up NDA approval by pulling back the target review period for the applications from some 10 months to 6 months. It is generally granted for medicines that offer "major advances in treatment, or provide a treatment where no adequate therapy exists".

As of now, there are no medicines approved in the US or Europe for IPF, which is a "progressive, disabling and ultimately fatal disease". It has been estimated that the condition affects about
200,000 people in the US.

"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", said Dan Welch, President, and Chief Executive of InterMune.

In October 2008, pirfenidone gained approval for use and marketing in Japan.