INGELHEIM, Germany. - Monday, January 19th 2015 [ME NewsWire]
• Nintedanib* slows disease progression by reducing the decline in lung function by 50% in a broad range of IPF patient types**
• Nintedanib* significantly reduced the risk of adjudicated acute exacerbations‡ by 68%
• EC approval is based on results from the replicate Phase III INPULSIS® trials, involving 1,066 patients from 24 countries
(BUSINESS
WIRE) 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.1
“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
~ENDS~
Please click on the link below for
‘Notes to Editors’ and ‘References’:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2015/19_january_2015_ipf.html
Contacts
Boehringer Ingelheim
Corporate Communications
Media + PR
Linda Calandra
Phone: +49 1511 502-1148
Fax: +49 (6132) 77-6601
Email: press@boehringeringelheim.com
Permalink: http://me-newswire.net/news/13399/en
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