Intermune’s Meeting with FDA expected (Nasdaq:ITMN)

Pirfenidone is a drug that has been developed by Intermune, Inc. (Nasdaq:ITMN). According to the company, this drug can be used to treat patients suffering from idiopathic pulmonary fibriosis (IPF) by keeping the lungs healthy. The company wants to bring the product into the market on November 4, 2009 – under the trade name Esbriet®. And a few weeks later, the FDA announced that the NDA contains all the information that would allow it to make a thorough review on pirfenidone – that is, the NDA was accepted for review. The FDA also handed the company a Prescription Drug User Fee Act goal date – also called Action date or just PDUFA date. This is the date on which the FDA must complete its review of the NDA and let Intermune know about whether it has accepted the NDA or not. Usually, it takes the FDA nine months to review a NDA submission. However, earlier, the FDA gave the NDA for pirfenidone both Orphan Drug and Fast Track designation and Priority Review designation since the FDA thinks that the drug, if approved, may provide significant progress in the treatment of IPF. This means that the FDA would complete reviewing pirfenidone’s NDA within 6 months. As a result, the PDUFA date is expected to be on May 4, 2010. Meanwhile, Intermune is preparing for the meeting with the Pulmonary-Allergy Drugs Advisory Committee (PADAC) of the FDA. The meeting will take place on March 9, 2010.

IPF is a common disease in the United States of America as well as in the rest of the world. As many as 30,000 people are diagnosed with this disease every year.  IPF is a fat disease. Most patients die within 2 to 5 years from the date of diagnosis of the IPF. This is because it inflames and scars the walls of the lungs, making it difficult for oxygen to pass through. The severity of the disease also increases over time – causing an alleviation of the symptoms. However, even now, there is no treatment for this dangerous disease.

The number of people suffering from IPF is also high in Europe. As a result, Intermune wants to market pirfenidone in the European Union, too. For this purpose, it proposed a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) – which is European equivalent to the US FDA – on March 2, 2010.