Boehringer Ingelheim Welcomes The Inclusion Of OFEV (Nintedanib*) In The Updated International Treatment Guidelines For Idiopathic Pulmonary Fibrosis (IPF)

• New guidance recommends OFEV^® (nintedanib*) for the treatment of IPF
• This recommendation puts a high value on the potential benefit of OFEV^® on patient-important outcomes such as disease progression as measured by rate of FVC decline and mortality

INGELHEIM, Germany--(BUSINESS WIRE)--Boehringer Ingelheim welcomes the international evidence-based 2015 ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis – An Update of the 2011 Guideline which suggests that clinicians use OFEV^® (nintedanib*) in patients with IPF***.¹

“These guidelines are important because they provide valuable recommendations to physicians to improve the treatment and management of devastating conditions like IPF. These new guidelines clearly emphasise the role of OFEV® in the treatment of IPF.”

The committee noted the high value of OFEV^® on patient-important outcomes such as disease progression as measured by rate of forced vital capacity (FVC) decline and mortality. The recommendation also takes into account the expected cost of treatment and potentially significant adverse effects. However, it noted that there was no increase in serious adverse events with OFEV^®, and relatively few patients discontinued the study drug secondary to adverse effects.¹

Dr Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom commented: “These guidelines are important because they provide valuable recommendations to physicians to improve the treatment and management of devastating conditions like IPF. These new guidelines clearly emphasise the role of OFEV^® in the treatment of IPF.”

Dr Christopher Corsico, Chief Medical Officer Boehringer Ingelheim commented: “The inclusion of OFEV^® in the international guideline marks an important step forward for patient care. Until recently no approved treatment options were recommended. OFEV^® offers IPF patients a convenient, twice daily medicine that slows disease progression across a broad range of IPF patients**, resulting in a 50% reduction in the annual rate of decline of lung function.”²

The committee analysed the evidence accumulated since the publication of the 2011 official guidelines and updated the treatment recommendations accordingly.³ OFEV^® has been studied in two replicate Phase 3 trials (INPULSIS^®-1 and INPULSIS^®-2) involving more than 1,000 patients in 24 countries² and a Phase II trial (TOMORROW) involving 432 patients.⁴

The joint guidelines committee consists of representatives from an international group of leading respiratory societies including the American Thoracic Society (ATS), European Respiratory Society (ERS), Japanese Respiratory Society (JRS) and Latin American Thoracic Association (ALAT).

Clinical data on OFEV^®

The INPULSIS^® clinical trials showed that OFEV^® had a consistent effect on annual rate of FVC decline, with a 50% reduction in the decline of lung function.² OFEV^® is the only treatment to significantly reduce the risk of adjudicated acute IPF exacerbations^? by 68%.² Acute exacerbations in IPF are associated with high morbidity and mortality. They are the leading cause of hospitalisation and death in patients with IPF.^5,6,7,8

In both INPULSIS^® trials, the most common adverse events were gastrointestinal in nature, of mild or moderate intensity, generally manageable and rarely leading to treatment discontinuation.²

About IPF

IPF is a fatal lung disease, with a median survival of 2 – 3 years after diagnosis.³ It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing.³ Worldwide, IPF affects as many as 14 – 43 people per 100,000,⁹ most commonly over the age of 50.³

*Nintedanib is approved under the brand name OFEV^® in the US and EU for use in patients with IPF. Nintedanib is under regulatory review by health authorities in other countries

‡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

**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

***This conditional recommendation means that clinicians are encouraged to discuss preferences with their patients when making treatment decisions

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Please click on the link below for ‘Notes to Editors’ and ‘References’:

http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/15_july_2015_ipf.html

Intended audiences:

This press release is issued from our Corporate Headquarters in Ingelheim, Germany and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved products may vary from country to country, and a country-specific press release on this topic may have been issued in the countries where we do business.

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