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FDA Grants breakthough therapy designation for InterMune’s pirfenidone

17 Jul 2014 (Last Updated July 17th, 2014 18:30)

InterMune has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its pirfenidone, an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF).

InterMune has received breakthrough therapy designation from the US Food and Drug Administration (FDA) for its pirfenidone, an investigational treatment for adult patients with idiopathic pulmonary fibrosis (IPF).

The company had submitted a new drug application to the FDA in May for pirfenidone and noted a target FDA review of six months under the Prescription Drug User Fee Act.

InterMune chairman, president and CEO Dan Welch said: "The breakthrough therapy designation underscores the significant need to help patients with this irreversible and ultimately fatal disease, particularly as no FDA-approved therapies are currently available.

"We are pleased that the FDA recognised the importance of pirfenidone as a potential new therapy for IPF, a disease with great unmet medical need."

"We are pleased that the FDA recognised the importance of pirfenidone as a potential new therapy for IPF, a disease with great unmet medical need."

An anti-fibrotic agent, pirfenidone inhibits the synthesis of TGF-beta and plays a key role in fibrosis. The drug also inhibits the synthesis of TNF-alpha, a cytokine that is known to have an active role in inflammation.

InterMune received marketing approval from the European Commission for Esbriet (pirfenidone) in February 2011 for treatment of adults with mild to moderate IPF. This approval authorised marketing of Esbriet in all 28 EU member states.

Health Canada has approved Esbriet in October 2012 and the company launched the IPF drug in January 2013.

Under different trade names, pirfenidone is also approved in China, India, Japan, South Korea, Argentina and Mexico. It is not approved for sale in the US.