InterMune Designated as Breakthrough Therapy by the FDA

The biopharmaceutical company InterMune, Inc. reports that pirfenidone, an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IFP), has been granted breakthrough therapy designation from the US Food and Drug Administration (FDA). 

Pirfenidone is an orally active, anti-fibrotic agent that inhibits the synthesis of TGF-beta, a chemical mediator that controls many cell functions, including proliferation and differentiation, and plays a key role in fibrosis.  Pirfenidone also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

On February 28, 2011, the European Commission (EC) granted marketing authorization for Esbriet(pirfenidone) for the treatment of adults with mild to moderate IPF. The approval authorized marketing of Esbriet in all 28 European Union member states. Esbriet has since been approved for marketing in Norway and Iceland. In 2011, InterMune launched commercial sales of pirfenidone in Germany under the trade name Esbriet, and Esbriet is now also commercially available in various European countries, including in France, Italy, and the UK. On October 1, 2012, Health Canada approved Esbriet for the treatment of mild to moderate IPF in adult patients. Health Canada designated Esbriet for priority review and completed the accelerated review according to target guidelines of 180 days. InterMune launched Esbriet in Canada in January 2013. Pirfenidone has been marketed as Pirespa since 2008 in Japan and since 2012 in South Korea by Shionogi & Co. Ltd.  Under different trade names, pirfenidone is also approved for the treatment of IPF in China, India, Argentina, and Mexico.

Pirfenidone is not approved for sale in the United States. In May 2014, InterMune resubmitted its new drug application for pirfenidone and noted a target FDA review of six months under the Prescription Drug User Fee Act. FDA’s breakthrough therapy designation designation is reserved for drugs that are intended to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. A drug designated as breakthrough therapy will receive expedited review by the FDA.

Source: InterMune

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