INGELHEIM, Germany - Monday, November 24th 2014 [ME NewsWire]

• Phase III INPULSIS® trials showed that nintedanib* slows disease progression in a broad range of IPF patient types** with a 50% reduction in the decline of lung function

• Nintedanib* significantly reduced the risk of adjudicated acute exacerbations‡ by 68%

• Positive opinion follows the recent FDA approval of nintedanib* for the treatment of patients with IPF

(BUSINESS WIRE)-- For media outside UK, US and Canada

Boehringer Ingelheim today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for nintedanib* (suggested brand name OFEV®) for the treatment of patients with idiopathic pulmonary fibrosis (IPF). Results from the Phase III INPULSIS® trials, published in the New England Journal of Medicine in May, showed that nintedanib* significantly slowed disease progression in a broad range of patients with IPF**.1 The opinion comes after the recent Food and Drug Administration (FDA) approval of nintedanib* for the treatment of IPF.

“Boehringer Ingelheim welcomes the decision by the CHMP. There has been a high unmet need for effective treatments that can slow disease progression in IPF. We look forward to making nintedanib available soon to patients with IPF in the EU,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.

IPF is a debilitating and fatal lung disease with a median survival of 2–3 years after diagnosis.2 It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing.3

“This decision is very encouraging as patients with IPF currently have very limited treatment options,” said INPULSIS® study investigator Professor Luca Richeldi, Professor of Respiratory Medicine, Chair of Interstitial Lung Disease at the University of Southampton, United Kingdom. “For the first time we have a drug that has consistently met the primary endpoint in two large Phase III trials, confirming the results of the Phase II trial.”

The CHMP’s positive opinion is based on pivotal data 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: this included 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.1 As well, nintedanib* significantly reduced the risk of adjudicated acute exacerbations‡ by 68%.1 This can be crucial given that approximately 50% of patients hospitalised for an acute IPF exacerbation die during hospitalisation.4

Nintedanib* in IPF has been granted accelerated assessment by the EMA. Nintedanib*, one capsule twice a day, is the first treatment for IPF that has consistently demonstrated a significant reduction in the decline in lung function and has a manageable side effect profile.1 More than 90% of eligible patients who participated in the INPULSIS® trials opted to continue with nintedanib* treatment as part of an open-label extension trial.5

*Nintedanib is currently being assessed by the European Medicines Agency (EMA) and other regulatory organisations worldwide

**INPULSIS® recruited a broad range of patient types – similar to those seen in clinical practice including patients with early disease (FVC > 90% pred), no honeycombing on HRCT and/or concomitant emphysema

‡Adjudicated exacerbations’ was a pre-specified sensitivity analysis in the pooled data set. Time to first Investigator-reported exacerbation was a secondary endpoint which was met in TOMORROW and INPULSIS®-2 but not in INPULSIS®-1

~ENDS~

Please click on the link below for ‘Notes to Editors’ and ‘References’: http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2014/21_november_2014_ipf.html

Contacts

Boehringer Ingelheim

Corporate Communications

Media + PR

Linda Calandra

Phone: +49 1511 502-1148

Fax: +49 (6132) 77-6601

Email: press@boehringeringelheim.com

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