European Medicines Agency (EMA) Accepts Accelerated Marketing Authorisation Application for nintedanib* in IPF

BRACKNELL, England, June 5, 2014 /PRNewswire/ --

• Acceptance of accelerated marketing authorisation application marks the beginning of the regulatory review process for nintedanib* in IPF in the EU 
• Application for nintedanib* in IPF is supported by data from two, identical Phase III trials involving more than 1,000 patients^[1]
• Data show that nintedanib* slows disease progression by reducing annual decline in lung function by half^[1]

Boehringer Ingelheim today announced that the European Medicines Agency (EMA) has accepted an accelerated marketing authorisation application for the review of nintedanib*, an investigational tyrosine kinase inhibitor (TKI) for the treatment of idiopathic pulmonary fibrosis (IPF).^[2] The acceptance of this marketing authorisation application marks the beginning of the review process in the European Union for this potential new treatment.

"IPF is a debilatating and fatal lung disease with limited treatment options available that can slow disease progression," said Dr Charles de Wet, UK Medical Director at Boehringer Ingelheim. "EMA approval will bring this much needed therapy one step closer to patients, who will ultimately benefit."

The marketing authorisation application for nintedanib* included results from two Phase III trials with identical design, INPULSIS™-1 and INPULSIS™-2, which showed that nintedanib* significantly slowed disease progression in patients with IPF (p<0.001).^[1] Data from the two 52-week trials, recently published in the New England Journal of Medicine, demonstrate that nintedanib* met the primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50% compared to patients taking placebo.^[1]

Nintedanib*, taken as one capsule twice daily, is the first targeted treatment for IPF that has consistently demonstrated the ability to slow disease progression by significantly reducing decline in lung function (p<0.001) with a manageable side effect profile.^[1]

Notes to Editors 

About nintedanib* 

Nintedanib* is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF).^[2] It has been granted orphan drug designation in the EU, United States and Japan.^[3]-[5]

Nintedanib* targets growth factor receptors, which have been shown to be potentially involved in the pathenogenesis of idiopathic pulmonary fibrosis, most importantly the vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR).^[6]

Nintedanib* is also in clinical development as a treatment option for cancer, including non-small cell lung cancer and ovarian cancer, and in earlier stages of development for renal cell cancer, colorectal cancer and hepatocellular cancer.^[7]

About idiopathic pulmonary fibrosis 

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately fatal lung disease for which there are limited treatment options.^[8] IPF is characterised by inflammation and scarring of lung tissue and loss of lung function over time.^[8];[9] This build-up of scar tissue is called 'fibrosis.' As the lung tissue becomes thick and stiff with scarring, the lungs lose their ability to take in oxygen from the air and transfer it to the bloodstream.^[10] As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities.^[11]

Every year in the UK, more than 5,000 people are diagnosed with the disease,^[12] with a median survival time of three years from diagnosis.^[13]

For more information please visit http://www.boehringer-ingelheim.co.uk

About 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 142 affiliates and a total of more than 47,400 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.

Taking 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 2013, Boehringer Ingelheim achieved net sales of about €14.1 billion. R&D expenditure corresponds to 19.5% of its net sales.

* Nintedanib is an investigational compound. Its safety and efficacy have not yet been fully established.

References

(1) Richeldi L, Du Bois R, Raghu G et al. Efficacy and Safety of nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med 2014; published online 18 May: DOI: 10.1056/NEJMoa1402584.

(2) Richeldi L, Costabel U, Selman M. Efficacy of a Tyrosine Kinase inhibitor in Idiopathic Pulmonary Fibrosis. N Engl J Med 2011; 365:1079-1087.

(3) Food and Drug Administration. Orphan Drug Designations and Approvals. 2011. Available at: http://www.accessdata.fda.gov/scripts/opdlisting/oopd/OOPD_Results_2.cfm?Index_Number=344511. Last accessed: June 2014.

(4) European Medicines Agency. Medicines for Rare Diseases. 2014. Available at: http://www.ema.europa.eu/ema/index.jsp?curl=pages/special_topics/general/general_content_000034.jsp&mid=WC0b01ac058002d4eb. Last accessed: June 2014.

(5) Ministry of Health, Labour and Welfare. List of products designated as orphan drugs for rare diseases. 2011. Available at: http://www.nibio.go.jp/shinko/orphan/english/pdf/h2412kisyoiyaku-hyo1.pdf. Last accessed: June 2014.

(6) Hilberg F, Roth G, Krssak M et al. BIBF 1120: Triple Angiokinase Inhibitor with Sustained Receptor BLockade and Good Antitumor Efficacy. Cancer Res 2008; 68:4774-4782.

(7) Boehringer Ingelheim. Nintedanib (BIBF 1120) fact sheet. 2013. Available at: http://us.boehringer-ingelheim.com/content/dam/internet/opu/us_EN/documents/Media_Press_Releases/2013/BI-Nintedanib-Fact-Sheet-2013.pdf. Last accessed: June 2014.

(8) Raghu G, Collard H, Egan J. 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.

(9) Bergeron A, Soler P, Kambouchner P. Cytokine profiles in idiopathic pulmonary fibrosis suggest an important role for TGF-b and IL-10. Eur Respir J 2003; 22:69-76.

(10) British Lung Foundation. Information sheet: Idiopathic pulmonary fibrosis and other types of interstitial lung disease. Available at: http://www.blf.org.uk/Conditions/Detail/IPF. Last accessed: June 2014.

(11) Pulmonary Fibrosis Foundation. Symptoms of Pulmonary Fibrosis. 2013. Available at: http://www.pulmonaryfibrosis.org/symptoms. Last accessed: June 2014.

(12) Navaratnam V. The rising incidence of idiopathic pulmonary fibrosis in the UK. Thorax 2011; 66:462-467.

(13) National Institute of Health and Care Excellence (NICE). Diagnosis and management of suspected idiopathic pulmonary fibrosis. 2013. Available at: http://www.nice.org.uk/nicemedia/live/14183/64119/64119.pdf. Last accessed: June 2014.