OFEV® (nintedanib*) approved in the EU for the treatment of IPF

Boehringer Ingelheim today announced that the European Commission (EC) has approved nintedanib* for the treatment of idiopathic pulmonary fibrosis (IPF), following an expedited review and positive CHMP opinion on 20 November 2014. Nintedanib* will be marketed in the EU under the brand name OFEV^®. IPF is a debilitating and fatal lung disease – with a median survival of 2-3 years after diagnosis.

“Approval of this treatment for patients in the EU is a significant step towards meeting the substantial unmet need in IPF. Patients suffering from this chronic, debilitating disease can now be offered a new treatment option that has been shown to have a clinically meaningful effect on their disease,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “This approval is another milestone in Boehringer Ingelheim’s ongoing efforts with regard to innovation in rare diseases in general and our continuing research for the benefit of patients affected by such a dreadful disease as IPF in particular.”

EC approval is based on results from the replicate Phase III INPULSIS^® trials, involving 1,066 patients from 24 countries. INPULSIS^® results showed that nintedanib* slowed disease progression by reducing the annual rate of decline in lung function by 50% in a broad range of IPF patient types including patients with early disease (forced vital capacity (FVC) >90% pred), limited radiographic fibrosis (no honeycombing) on high resolution computed tomography (HRCT) and those with emphysema.² Nintedanib*, only one capsule twice a day, is the first targeted treatment for IPF to consistently meet the primary endpoint in two identically designed Phase III trials. Nintedanib* has been shown to significantly reduce the risk of adjudicated acute exacerbations^‡
by 68%.²

Study investigator Professor Luca Richeldi, Professor of Respiratory Medicine, Chair of Interstitial Lung Disease at the University of Southampton, United Kingdom, said “Until recently, treatment options for patients with IPF were limited. The approval of nintedanib* in the EU gives patients with a life threatening illness a choice of therapy with proven efficacy. Clinical data demonstrate that nintedanib* reduces the annual decline of lung function by approximately half. Data also showed that nintedanib* reduced the risk of acute exacerbations, which can lead to hospitalisation and death.”

Worldwide IPF affects as many as 14–43 people per 100,000.^3,4 It most commonly affects people over the age of 50.⁵ IPF causes permanent scarring of the lungs and decreases the amount of oxygen the lungs can supply to major organs of the body.^6,7

“It’s great that there is now a choice of treatments for IPF patients. This approval provides important hope for patients and caregivers living with this awful disease,” said Dr Toby Maher, Consultant Respiratory Physician at the Royal Brompton Hospital in London, United Kingdom.

*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
**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
‡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

References

1. 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.
2. Richeldi L, et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med. 2014;370:2071-82.
3. Raghu G, et al. Incidence and prevalence of idiopathic pulmonary fibrosis.
   Am J Respir Crit Care Med. 2006;174:810-816.
4. Fernández Pérez E, et al. Incidence, prevalence, and clinical course of idiopathic pulmonary fibrosis: a population-based study. Chest. 2010;137:129-37.
5. American Thoracic Society. Idiopathic Pulmonary Fibrosis: Diagnosis and Treatment. Am J Respir Crit Care Med. 2000;161:646–664.
6. Collard H, et al. Acute Exacerbations of Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2007;176:636–643.
7. NHLBI, NIH. What Is Idiopathic Pulmonary Fibrosis? nhlbi.nih.gov/health/health-topics/topics/ipf/. Last Accessed January 2015.