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European Medicines Agency Accepts Boehringer Ingelheim Corporation's Marketing Authorization Application For Nintedanib For IPF

6/5/2014 7:25:38 AM

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EMA Accepts Marketing Authorization Application For Nintedanib In IPF

Ingelheim, Germany, 05. June 2014 – Boehringer Ingelheim today announced that the application for marketing authorisation of nintedanib*, a tyrosine kinase inhibitor (TKI), for the treatment of idiopathic pulmonary fibrosis (IPF) has been validated and granted accelerated assessment by the European Medicines Agency (EMA).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 relentless and fatal lung disease, and there is a high unmet need for effective treatments that can slow disease progression," said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. "Acceptance of our marketing authorisation application takes us one step closer to meeting this unmet need and providing a new treatment option to patients living with IPF."

The marketing authorisation application for nintedanib* included results from two Phase III trials with identical design, INPULSIS™-1 and INPULSIS™-2, which show nintedanib* significantly slowed disease progression in patients with IPF. 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 This effect on disease progression was further supported in the pooled data set by a positive signal in reducing the risk of acute exacerbations by 38% (p=0.08) and a significant risk reduction in confirmed or suspected acute exacerbations by 68% (p=0.005).

Nintedanib*, two capsules a day, is the first targeted treatment for IPF that has consistently demonstrated to slow disease progression in IPF by significantly reducing the decline in lung function by half with a manageable side effect profile. Boehringer Ingelheim is committed to making nintedanib* available to patients with IPF and is prepared to respond to requests for compassionate use, subject to local regulations.

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

About nintedanib*
Nintedanib* is an investigational small molecule tyrosine kinase inhibitor (TKI) in development by Boehringer Ingelheim for idiopathic pulmonary fibrosis (IPF).2 It targets growth factor receptors, which have been shown to be potentially involved in pathomechanisms of pulmonary fibrosis, most importantly the platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR) and vascular endothelial growth factor receptor (VEGFR).2,3,4 By blocking the signalling pathways that are involved in fibrotic processes, it is believed that nintedanib* has the potential to reduce disease progression in IPF by slowing the decline of lung function.2,3,5 Nintedanib* is also in clinical development as a treatment option for cancer, including non-small cell lung cancer, ovarian cancer, colorectal cancer and hepatocellular carcinoma.

About idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, severely debilitating and ultimately lethal lung disease for which there are limited treatment options.6 IPF affects as many as 14–43 people per 100,000 worldwide.7,8 IPF is characterised by progressive scarring of lung tissue and loss of lung function over time.3,9 Development of scarred tissue is called fibrosis.6 Over time, as the tissue thickens and stiffens with scarring, the lungs lose their ability to take in and transfer oxygen into the bloodstream, and vital organs do not get enough oxygen.10 As a result, individuals with IPF experience shortness of breath, cough and often have difficulty participating in everyday physical activities.11

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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.

1Richeldi L, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis N Engl J Med. 2014; published online on May 18; DOI: 10.1056/NEJMoa1402584
2Richeldi L, et al. Efficacy of a tyrosine kinase inhibitor in idiopathic pulmonary fibrosis. N Engl J Med. 2011;365:1079-1087.
3Selman M, et al. Idiopathic pulmonary fibrosis: prevailing and evolving hypotheses about its pathogenesis and implications for therapy. Ann Intern Med. 2001;134:136-51.
4Hilberg F, et al. BIBF 1120: triple angiokinase inhibitor with sustained recptor blockade and good antitumor efficacy.Cancer Res. 2008;68:4774-4782.
5Wollin L, et al. Antifibrotic and Anti-inflammatory Activity of the Tyrosine Kinase Inhibitor Nintedanib in Experimental Models of Lung Fibrosis. J Pharmacol Exp Ther 2014;349:209–220.
6Raghu 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.
7Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med.2006;174:810-816.
8Fernández Pérez E, et al. Incidence, prevalence, and clinical course of idiopathic pulmonary fibrosis: a population-based study. Chest. 2010;137:129-37.
9NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? Accessed April 2014.
10Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176:636–643.
11Pulmonary Fibrosis Foundation. Symptoms. Accessed March 2014.

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