InterMune, Inc. today announced that it has resubmitted its pirfenidone New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in response to a Complete Response Letter (CRL) received in May 2010.  Pirfenidone is being developed for the treatment of adult patients with idiopathic pulmonary fibrosis (IPF). 

"We are pleased to have resubmitted the pirfenidone NDA and look forward to our interactions with the FDA," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune.  "The final steps in preparing the resubmission were completed very smoothly and efficiently, allowing us to complete the process somewhat earlier than expected.  If the FDA grants approval of our NDA within the six-month review period of an NDA resubmission, we would be ready to launch pirfenidone in the first quarter of 2015."

Under the Prescription Drug User Fee Act (PDUFA), the FDA has 74 days after receipt of an NDA to evaluate the submission in order to determine if it is sufficiently complete.  If in this 74-day period the FDA determines that the submission is complete, the review clock will be deemed to have started as of the date that the resubmission was initially received by the FDA.  As the resubmission of an efficacy supplement, the submission of the ASCEND data represents a Class 2 resubmission that has a target FDA review of six months under PDUFA V.

In May 2010, InterMune received a CRL from the FDA.  In the CRL, the FDA recommended an additional Phase 3 clinical trial to support the efficacy of pirfenidone.  Since the receipt of the CRL, InterMune has conducted the Phase 3 ASCEND trial of pirfenidone in IPF, and results of that trial were presented on May 18, 2014, at the meeting of the American Thoracic Society and were published on-line the same day in the New England Journal of Medicine.  The NDA resubmission includes the ASCEND Clinical Study Report as well as the pooled analyses of efficacy and mortality from the three InterMune Phase 3 trials: ASCEND and the previous Phase 3 CAPACITY trials (004 and 006).  Additionally, the NDA resubmission includes a safety update of approximately 15,000 patients including clinical studies and the extensive post-marketing experience of pirfenidone collected since 2008.

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