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Boehringer Ingelheim receives EU approval for idiopathic pulmonary fibrosis drug
Boehringer Ingelheim has had a new treatment for idiopathic pulmonary fibrosis approved by the European Commission.
The drug nintedanib has been ratified for sale based on results from the replicate phase III Inpulsis trials, which demonstrated the product's safety and efficacy among 1,066 patients from 24 countries. It will be marketed under the brand name Ofev.
In the clinical studies, the therapy was shown to slow disease progression by reducing the decline in lung function by 50 percent across a broad range of patient types, while it significantly reduced the risk of adjudicated acute exacerbations by 68 percent.
Idiopathic pulmonary fibrosis is a debilitating and fatal disease that causes permanent scarring of the lungs, thus decreasing the amount of oxygen supplied to major organs. Most patients survive only two to three years after diagnosis.
Professor Klaus Dugi, chief medical officer of Boehringer Ingelheim, 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 comes after the company received European approval for its lung cancer therapy Vargatef in November 2014.
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