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news.InterMune, a California-based biotechnology company that develops and commercializes innovative therapies in pulmonology and hepatology, has received marketing authorization for Esbriet (pirfenidone) in all 27 EU member states from the European Commission (EC).
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Esbriet is a small-molecule drug which is orally active, and inhibits the synthesis of TGF-beta, a chemical mediator that controls several cell functions and is important in fibrosis.
It also inhibits the synthesis of TNF-alpha, a cytokine believed to playan active role in inflammation.
Esbriet is indicated for the treatment of mild to moderate idiopathic pulmonary fibrosis (IPF) in adults.
The approval will go a long way in helping over 87,000 patients in the five largest countries in Europe; namely Germany, France, Spain, Italy and the UK.
Currently, InterMune plans to launch Esbriet in Germany (September of 2011), France, Spain and Italy in the first half of 2012 and in the UK in mid-2012.
Plans are also underway to launch Esbriet in all or substantially all of the 10 most important pharmaceutical markets in the EU by approximately mid-2012.
InterMune CEO, chairman and president Dan Welch said the company’s leadership team in the EU was working diligently to make Esbriet available to European patients, beginning with Germany as early as September 2011.
Esbriet Phase 3 clinical program co-chair and Imperial College professor of respiratory medicine Roland du Bois said the approval is a landmark event in IPF care, as it will extend the scope of a novel treatment shown to have a clinically meaningful effect to IPF patients.