ITMN - Complete Response Letter - FDA requests additional trial
InterMune Receives FDA Complete Response Letter on Esbriet(TM) (Pirfenidone) New Drug Application
-- Conference Call Scheduled at 4:30 p.m. EDT, May 4, 2010 --
Press Release Source: InterMune, Inc. On Tuesday May 4, 2010, 4:00 pm
BRISBANE, Calif., May 4 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq:ITMN - News) today announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter for the New Drug Application (NDA) for Esbriet™ (pirfenidone) for the treatment of patients with idiopathic pulmonary fibrosis (IPF) to reduce decline in lung function.
A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review of an application is completed, but there are one or more reasons that preclude the approval of the NDA at this time. The FDA has requested an additional clinical trial to support the efficacy of Esbriet in IPF patients. InterMune intends to meet with the FDA as soon as possible to explore the best ways to address the points raised by the Agency and to discuss pathways to approval.
"After the positive FDA Advisory Committee meeting of March 9 at which the Committee recommended the approval of the pirfenidone NDA by a 9-3 margin, we are disappointed by this outcome," said Dan Welch, Chairman, Chief Executive Officer and President of InterMune. "We will meet with the FDA as soon as possible to understand their points of view and to determine the most appropriate path forward to expeditiously make Esbriet available to the approximately 100,000 patients with IPF and their families who suffer from this terrible disease and for whom no FDA-approved medicines exist."
Conference Call and Webcast Details
InterMune will host a conference call today at 4:30 p.m. EDT to discuss Esbriet. Interested parties may participate in the conference call by dialing 1-888-799-0528 (U.S.) or 1-973-200-3372 (international), conference ID# 73229257. A replay of the webcast and teleconference will be available approximately three hours after the call.
To access the webcast, please log on to InterMune's website at www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
The teleconference replay will be available for 10 business days following the call and can be accessed by dialing 1-800-642-1687 (U.S.) or 1-706-645-9291 (international), and entering the conference ID# 73229257.
