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Home Industry News Boehringer Ingelheim announces CHMP recommendation of Pradaxa

Boehringer Ingelheim announces CHMP recommendation of Pradaxa

28th January 2008

Boehringer Ingelheim has announced that the Committee for Medicinal Products in Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive recommendation to give marketing authorisation to Pradaxa (dabigatran etexilate).

The committee has recommended that the compound be approved as a treatment for the prevention of venous thromboembolic events in patients who have undergone total knee replacement surgery or total hip replacement surgery.

Given as a fixed dose, Pradaxa can be administered to patients both in and outside of hospital to provide individuals with effective protection from potentially dangerous blood clots following surgery.

The marketing application from Boehringer Ingelheim included results from the Re-Novate and Re-Model trials, while all test results were evaluated by a blinded central adjudication committee.

Andreas Barner, board member responsible for research, development and medicine at the firm, said: “We welcome the positive opinion of the EMEA which is the first recommendation for approval by a regulatory authority for our novel oral anticoagulant drug Pradaxa.”

He added that the announcement represents important progress in the development of anticoagulation therapy for thromboembolic diseases.

Last month, Boehringer Ingelheim announced an extension in the Re-Volution trial of dabigatran etexilate to include patients with acute coronary syndrome.

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