ME Newswire / Business Wire
INGELHEIM, Germany - Tuesday, November 26th 2013
Accelerated assessment reserved for medicinal products of major
interest from the viewpoint of public health and therapeutic innovation1
Submission based on comprehensive development programme including the
Phase III STARTVerso™ data aiming to demonstrate the efficacy and safety
of faldaprevir* + PegIFN/RBV in a broad range of genotype-1 infected
hepatitis C patients2,3,4
For media outside of the U.S.A., UK and Canada only
The
application for European marketing authorisation of faldaprevir*, a
potent second generation oral protease inhibitor, has been fully
validated and granted accelerated assessment by the European Medicines
Agency (EMA).5,6 Boehringer Ingelheim is seeking marketing approval of
faldaprevir* in combination with pegylated interferon and ribavirin
(PegIFN/RBV) for the treatment of a broad range of patients with
genotype-1 (GT-1) hepatitis C, including difficult-to-cure populations
such as those with HIV co-infection or advanced liver disease.
“Faldaprevir*
has been studied with pegylated interferon and ribavirin in a broad
range of more than 3,300 patients typical of those that doctors see in
every day clinical practice. Faldaprevir* has demonstrated strong
efficacy and a robust safety profile while also offering the convenience
of once-daily dosing and no food restrictions,” said Professor Klaus
Dugi, Corporate Senior Vice President Medicine at Boehringer Ingelheim.
“The acceptance for accelerated assessment by the EMA supports our
position that if approved, faldaprevir* will provide an important
alternative to currently available hepatitis C treatments.”
Accelerated
assessment status does not automatically lead to a positive opinion
from the Committee for Medicinal Products for Human Use (CHMP) or the
granting of a marketing authorization by the European Commission.1 If
approved by the European Commission, faldaprevir* could be available for
marketing in the EU in the second half of 2014.
The EMA
Marketing Authorisation Application is based on a comprehensive clinical
development programme for faldaprevir* with a particular focus on the
Phase III STARTVerso™ trial data, recently presented at the 64th Annual
Meeting of the American Association for the Study of Liver Diseases
(AASLD). These studies include data for faldaprevir* in:
Treatment naïve patients with the majority having benefited from shorter treatment duration and achieved viral cure2
Difficult-to-cure patient populations such as those with HIV co-infection4 or advanced liver disease2,3
Patients with the Q80K polymorphism (this mutation is considered to
affect the efficacy of other second generation protease inhibitors)2
Treatment experienced patients who have relapsed, partially responded or failed to respond to previous therapy3
For full results see the STARTVerso™ press release here.
Faldaprevir*
is the foundation of Boehringer Ingelheim’s hepatitis C treatment
pipeline and is being developed in combinations both with and without
interferon. In addition to the interferon-based faldaprevir* regimen
that has been submitted for marketing approval, Boehringer Ingelheim
aims to deliver one of the first interferon-free regimens for the
treatment of hepatitis C infection. The goal is to make an
interferon-free future a reality for a broad range of hepatitis C
patients. Pivotal Phase III HCVerso® data for the interferon-free
regimen of faldaprevir*, deleobuvir* and ribavirin will be available in
2014.
* Faldaprevir and deleobuvir are investigational compounds
and not yet approved. Their safety and efficacy have not yet been fully
established.
NOTES TO EDITORS
The Boehringer Ingelheim NewsHome: An innovative resource for journalists
The
Boehringer Ingelheim hepatitis C www.newshome.com is the one-stop-shop
for clear, concise and easy to understand information about hepatitis C
for media.
For the full ‘Notes to Editors’ and ‘References’
please visit:
http://www.boehringer-ingelheim.com/news/news_releases/press_releases/2013/26_november_2013hcv.html
Contacts
Contact: Reinhard Malin
Boehringer Ingelheim
Corporate Communications
Media + PR
Reinhard Malin
55216 Ingelheim/Germany
Tel: +49 (6132) 77-90815
Fax: +49 (6132) 77-6601
Email: press@boehringer-ingelheim.com
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