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

Dr Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom
Dr Toby Maher,
Consultant
Respiratory
Physician at the
Royal Brompton
Hospital in London,
United Kingdom

Ingelheim, Germany 15 July 2015 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

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 Chris Corsico, Chief Medical Officer Boehringer Ingelheim
Dr Chris Corsico,
Chief Medical Officer
Boehringer Ingelheim

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 countries 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%. 2Acute 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

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

Notes to Editor

Boehringer Ingelheim

The Boehringer Ingelheim group is one of the world’s 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, Boehringer Ingelheim operates globally with 146 affiliates and a total of more than 47,700 employees. The focus of the family-owned company, founded in 1885, is researching, developing, manufacturing and marketing new medications of high therapeutic value for human and veterinary medicine.

Social responsibility is an important element of the corporate culture at Boehringer Ingelheim. This includes worldwide involvement in social projects, such as the initiative “Making more Health” and caring for the employees. Respect, equal opportunities and reconciling career and family form the foundation of the mutual cooperation. In everything it does, the company focuses on environmental protection and sustainability.

In 2014, Boehringer Ingelheim achieved net sales of about 13.3 billion euros. R&D expenditure corresponds to 19.9 per cent of its net sales.

For more information please visit www.boehringer-ingelheim.com

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.

Footnotes

*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

Referências

  1. Raghu G, et al; An Official ATS/ERS/JRS/ALAT Clinical Practice Guidelines: Treatment of Idiopathic Pulmonary Fibrosis: Executive Summary. American Journal of Respiratory and Critical Care Medicine Volume 192 (2) July 2015
  2. Richeldi L, du Bois RM, Raghu G, et al; for the INPULSIS Trial Investigators. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med. 2014;380(22):2071-2082.
  3. Raghu G, et al. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011;183:788-824.
  4. Richeldi L, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365:1079-1087.
  5. Collard HR, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176 (7):636-43.
  6. Song JW, Hong S-B, Lim C-M, Koh Y, Kim DS. Acute exacerbation of idiopathic pulmonary fibrosis: incidence, risk factors and outcome. Eur Respir J. 2011;37(2):356-363.
  7. Collard HR, et al. Suspected acute exacerbation of idiopathic pulmonary fibrosis as an outcome measure in clinical trials. Respir Res. 2013;14:73.
  8. Daniels CE et al. Autopsy findings in 42 consecutive patients with idiopathic pulmonary fibrosis. Eur Respir J 2008; 32:170-4.
  9. Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis.Am J Respir Crit Care Med. 2006;174:810-816.