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Home Industry News Boehringer Ingelheim receives EU recommendation for Pradaxa approval

Boehringer Ingelheim receives EU recommendation for Pradaxa approval

20th April 2011

Boehringer Ingelheim's new atrial fibrillation (AF) treatment Pradaxa (dabigatran etexilate) has been recommended for approval in Europe.

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion on the novel oral anticoagulant, which is designed to prevent stroke and systemic embolism among AF patients.

It comes after the treatment demonstrated its efficacy in this specification during the RE-LY clinical trial, during which its benefits compared to warfarin were observed.

The drug has already been approved in territories such as the US and Japan and represents the first new therapy option for this indication in more than 50 years.

Professor Klaus Dugi, corporate senior vice-president for medicine at Boehringer Ingelheim, said: "The positive opinion from the CHMP for dabigatran etexilate represents another significant milestone in the history of stroke prevention in AF."

Earlier this month, the firm announced plans to begin a phase III study of another promising new compound, BI 201335, which is specified as a hepatitis C therapy.ADNFCR-8000103-ID-800506930-ADNFCR

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