European Commission approves third nintedanib indication in pulmonary fibrosis

发布时间： 2020-07-28 阅读：569次

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July15, 2020 ? Boehringer Ingelheim today announced that the European Commission (EC) has approved an additional indication for nintedanib in adults for the treatment of other chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype beyond idiopathic pulmonary fibrosis (IPF). The U.S. Food and Drug Administration (FDA), Health Canada and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) recently approved nintedanib as the first treatment for the same patient population.

“Making your voice heard when living with a rare life-threatening condition can be very hard and also frightening, especially if no treatment option is available,” said Liam Galvin, Secretary of the European Idiopathic Pulmonary Fibrosis and Related Disorder Federation (EU-IPFF). “The European Commission’s decision is great news for people who are at risk of developing pulmonary fibrosis due to a progressive ILD. Pulmonary fibrosis causes irreversible decline in lung function and this new indication brings much hope to those affected and their loved ones.”

“We are very pleased with the European Commission’s decision to approve nintedanib as the first treatment in the EU for a group of chronic fibrosing ILDs that are progressing,” added Peter Fang, Senior Vice President and Head of Therapeutic Area Inflammation at Boehringer Ingelheim. “Living with fibrotic diseases greatly impacts the lives of the affected. Various underlying diseases can lead to the development of pulmonary fibrosis and until now, no treatment option was available. Bringing new hope to those patients constitutes a therapeutic breakthrough.”