Rare Disease Report

The European Commission Approves Nintedanib for Idiopathic Pulmonary Fibrosis

JANUARY 18, 2015
James Radke

The European Commission (EC) has approved Ofev (nintedanib) for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

IPF is a chronic, progressive fibrosing interstitial pneumonia that does not have a clear cause. In most cases, the disease is fatal within 2-3 years of initial symptoms and treatment options are limited. Current treatments (until now) included oxygen therapy, pulmonary rehabilitation, and lung transplant. In the United States, both nintedanib and pirfenidone (Esbriet) were approved by the US Food and Drug Administration (FDA) last October. Click here for details.

Nintedanib is a tyrosine kinase inhibitor that blocks multiple pathways that may be involved in the scarring of lung tissue. EC approval is based on results from the replicate Phase III INPULSIS trials, involving 1,066 patients from 24 countries. INPULSIS results showed that nintedanib slowed disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types including patients with early disease (forced vital capacity (FVC) >90% pred), limited radiographic fibrosis (no honeycombing) on high resolution computed tomography (HRCT) and those with emphysema. Nintedanib is administered orally twice a day.

Study investigator Luca Richeldi, MD, PhD, Professor of Respiratory Medicine, Chair of Interstitial Lung Disease at the University of Southampton said:

“Until recently, treatment options for patients with IPF were limited. The approval of nintedanib in the EU gives patients with a life threatening illness a choice of therapy with proven efficacy. Clinical data demonstrate that nintedanib reduces the annual decline of lung function by approximately half. Data also showed that nintedanib reduced the risk of acute exacerbations, which can lead to hospitalisation and death.”

Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim said:
“Approval of this treatment for patients in the EU is a significant step towards meeting the substantial unmet need in IPF. 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.”

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