BRACKNELL, England--(BUSINESS WIRE)--Boehringer Ingelheim is delighted to welcome the news that, following a full technology appraisal, OFEV® (nintedanib) is now recommended for use by NICE within the National Health Service (NHS) in England and Wales.1
NICE has recommended OFEV® for use in adult patients with IPF with a predicted forced vital capacity (FVC) between 50% and 80%. The recommendation states that OFEV®, compared to placebo, reduces the decline in pulmonary function assessed by FVC in patients with IPF.1
The full recommendation can be found here: www.nice.org.uk/guidance/TA379
In coming to its decision, the NICE Appraisal Committee considered the clinical evidence for nintedanib from 3 multicentre, double-blind, placebo-controlled, randomised trials comprising 2 phase III trials (INPULSIS 1 [n=513] and INPULSIS 2 [n=548]) and a phase IIb dose-ranging trial (TOMORROW [n=428]). All 3 trials compared nintedanib with placebo for 52 weeks in adults of 40 years or older with IPF. The primary outcome was the rate of decline (ml per year) in forced vital capacity (FVC).1 The trials demonstrated OFEV® significantly slowed the annual rate of decline in FVC in patients with IPF.2 OFEV® was the first targeted treatment for IPF to consistently meet its primary endpoint in two international Phase III trials with identical design.
Additionally, in a pooled analysis of the 3 phase II/III trials nintedanib reduced the risk of having one or more exacerbation compared to placebo.3
Welcoming the news Professor Klaus Dugi, Medical Director and Managing Director, BI UK and Ireland said, “This NICE recommendation for OFEV® is very welcome news for patients in England and Wales who have this devastating disease, as it gives doctors a much needed new option in the management of IPF. At Boehringer Ingelheim, we have over 90 years of experience in the field of respiratory medicine and are delighted to be leading the way in bringing this novel medicine to people with IPF.”
Mr Mike Bray, Chair of Action for Pulmonary Fibrosis, made the following statement:
“Having been involved in the NICE appraisal process, Action for Pulmonary Fibrosis is very pleased that nintedanib has been approved for the treatment of patients with IPF. With no cure and very limited treatment options, nintedanib offers an alternative therapy which will be much welcomed by patients.”
About IPF
IPF is a progressive and severely debilitating lung disease with a high mortality rate.4 It causes progressive scarring of the lungs, resulting in continual and irreversible deterioration in lung function and difficulty breathing.5 In patients with IPF, lung function loss is measured by a decline in a patient’s FVC, the maximum volume of breath that can be exhaled during a forced breath.
Every year in the UK, more than 5,000 people are diagnosed with the disease,6 with a median survival time of three years from diagnosis.5
About OFEV®
OFEV® is a small molecule tyrosine kinase inhibitor (TKI) taken orally.7 It targets growth factor receptors which studies have implicated in the pathogenesis of IPF. OFEV®’s mechanism of action is thought to occur through inhibiting 3 of these TKIs; vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet‐derived growth factor receptor (PDGFR).
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 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.co.uk.
REFERENCES
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1. |
NICE TA379 – Available at: www.nice.org.uk/guidance/ta379 |
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2. |
Richeldi L, Du Bois R, Raghu G et al. Efficacy and Safety of nintedanib in Idiopathic Pulmonary Fibrosis. N Eng J Med 2014; published online 18 May: DOI: 10.1056/NEJ Moa1402584. |
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3. |
Richeldi L, Brown K, Cottin V et al. Pooled analysis of data from the TOMORROW and INPULSIS® trials of nintedanib in IPF. Poster presentation at the British Thoracic Society Winter Meeting, London, 2 - 4 Dec 2015 |
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4. |
Raghu G, Collard HR, Egan JJ, 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. |
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5. |
Idiopathic pulmonary fibrosis in adults: diagnosis and management NICE guidelines [CG163] Published date: June 2013 Available at: http://www.nice.org.uk/guidance/cg163 Last accessed: January 2016 |
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6. |
Navaratnam V. The rising incidence of idiopathic pulmonary fibrosis in the UK. Thorax 2011; 66:462-467. |
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7. |
Richeldi L, Costabel U, Selman M. Efficacy of a Tyrosine Kinase inhibitor in Idiopathic Pulmonary Fibrosis. N Engl J Med 2011; 365:1079-1087 |
