Germany-based Boehringer Ingelheim has received approval from European Commission (EC) for its nintedanib to treat patients with idiopathic pulmonary fibrosis (IPF).
Nintedanib is a small molecule tyrosine kinase inhibitor, which is developed by Boehringer Ingelheim. The company will market nintedanib under the brand name OFEV in the EU.
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Boehringer Ingelheim chief medical officer professor Klaus Dugi said: "Patients suffering from this chronic, debilitating disease can now be offered a new treatment option that has been shown to have a clinically meaningful effect on their disease.
"This approval is another milestone in Boehringer Ingelheim’s ongoing efforts with regard to innovation in rare diseases in general and our continuing research for the benefit of patients affected by such a dreadful disease as IPF in particular."
Approval was based on results from the replicate Phase III Inpulsis trials, which involved 1,066 patients from 24 countries.
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According to the company, Inpulsis demonstrated the drug slowed disease progression by reducing annual rate of decline in lung function by 50% in a broad range of IPF patient types including patients with early disease, limited radiographic fibrosis and those with emphysema.
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By GlobalDataUK University of Southampton Interstitial Lung Disease chair and study investigator professor Luca Richeldi said: "The approval of nintedanib in the EU gives patients with a life threatening illness a choice of therapy with proven efficacy."
Nintedanib received FDA approval to treat IPF in October 2014, while the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion to treat IPF in November 2014.
Image: High-resolution computed tomography scans of the chest of a patient with IPF. Photo: courtesy of IPFeditor.
