Saturday, June 7, 2014

EMA Accepts Marketing Authorisation Application for Nintedanib in IPF

INGELHEIM, Germany. - Thursday, June 5th 2014 [ME NewsWire]

    Acceptance of marketing authorisation application marks the beginning of regulatory review process for nintedanib* in IPF in EU
    EMA has accepted the request for accelerated assessment
    Application for nintedanib* in IPF is supported by pivotal data from two replicate Phase III trials involving more than 1,000 patients
    Data show that nintedanib* consistently slows disease progression by reducing annual decline in lung function by half

(BUSINESS WIRE) For non-US health media only

Boehringer Ingelheim today announced that the application for marketing authorisation of nintedanib*, a tyrosine kinase inhibitor (TKI), for the treatment of idiopathic pulmonary fibrosis (IPF) has been validated and granted accelerated assessment by the European Medicines Agency (EMA).The acceptance of this marketing authorisation application marks the beginning of the review process in the European Union for this potential new treatment.

“IPF is a relentless and fatal lung disease and there is a high unmet need for effective treatments that can slow disease progression,” said Professor Klaus Dugi, Chief Medical Officer, Boehringer Ingelheim. “Acceptance of our marketing authorisation application takes us one step closer to meeting this unmet need and providing a new treatment option to patients living with IPF.”

The marketing authorisation application for nintedanib* included results from two Phase III trials with identical design, INPULSIS™-1 and INPULSIS™-2, which showed nintedanib* significantly slowed disease progression in patients with IPF. Data from the two 52-week trials, recently published in the New England Journal of Medicine, demonstrate that nintedanib* met the primary endpoint by significantly reducing the annual decline in forced vital capacity by approximately 50% compared to patients taking placebo.1 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 exacerbations by 68% (p=0.005).

Nintedanib*, two capsules a day, is the first targeted treatment for IPF that has consistently demonstrated to slow disease progression in IPF by significantly reducing the decline in lung function by half with a manageable side effect profile.

Boehringer Ingelheim is committed to making nintedanib* available to patients with IPF and is prepared to respond to requests for compassionate use, subject to local regulations.

*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’:


Boehringer Ingelheim

Corporate Communications

Media + PR

Linda Calandra

Phone: +49 1511 502-1148

Fax: +49 (6132) 77-6601



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