INGELHEIM, Germany. - Thursday, July 17th 2014 [ME NewsWire]
(BUSINESS WIRE) For non-U.S. Media Only
Boehringer Ingelheim today announced that for the first time the U.S. Food & Drug Administration (FDA) has granted Breakthrough Therapy designation for a treatment in idiopathic pulmonary fibrosis (IPF), a devastating and fatal lung disease. Nintedanib* is an investigational therapy currently under FDA and European Medicines Agency (EMA) review for IPF.
“We’re excited nintedanib* has been granted Breakthrough Therapy designation in the US, which we hope will make the treatment available to IPF patients as quickly as possible. Currently there are no FDA-approved treatments available for IPF. We are committed to working with all regulatory bodies to make nintedanib* available to people living with this serious and life-threatening lung disease,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim.
The Breakthrough Therapy designation process was established by the FDA in 2012. It is intended to facilitate and expedite the development and review of treatments for serious or life-threatening conditions if preliminary clinical evidence indicates that the therapy may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.1
IPF is a debilitating and fatal lung disease that causes permanent scarring of the lungs, difficulty breathing and decreases the amount of oxygen the lungs can supply to the major organs of the body.2 IPF affects as many as 14-43 people per 100,000 worldwide.3
Results from two global Phase III studies (INPULSIS™-1 and INPULSIS™-2) evaluating the efficacy and safety of nintedanib* for the treatment of IPF were presented at the American Thoracic Society (ATS) International Conference and published in the New England Journal of Medicine in May 2014.4
Nintedanib* is the first targeted treatment for IPF that has consistently demonstrated to slow disease progression in IPF by significantly reducing the annual decline in lung function by approximately 50%.4
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 exacerbation by 68% (p=0.005).4
*Nintedanib is an investigational compound. Its safety and efficacy have not yet been fully established.
Please click on the link below for ‘Notes to Editors’ and ‘References’:
1 U.S. Food and Drug Administration/Center for Drug Evaluation and Research/Center for Biologics Evaluation and Research. (2014) Guidance for Industry: Expedited Programs for Serious Conditions - Drugs and Biologics. Silver Spring, MD.
2 Raghu G., et al. An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management. American Journal of Respiratory and Critical Care Medicine. 2011; 183: 788–824, 2011.
3 Raghu G., et al. Incidence and prevalence of idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2006; 174:810-816
4 Richeldi, L., et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. New England Journal of Medicine. 2014, Vol. 370, pp.2071-2082. Published online on May 18, 2014.
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