Boehringer Ingelheim receives CHMP backing for new Pradaxa indication

Pharmaceutical Company Product News

Boehringer Ingelheim has received a recommendation from Europe's Committee for Medicinal Products for Human Use (CHMP) for approval of a new indication for its anticoagulant Pradaxa.

The European Medicines Agency committee has issued a positive opinion recommending approval of Pradaxa (dabigatran etexilate) in the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as for the prevention of recurrent DVT and PE in adults.

“Boehringer Ingelheim has received a European CHMP recommendation for approval of Pradaxa as a treatment for deep vein thrombosis and pulmonary embolism.“

Four phase III clinical trials involving almost 10,000 patients have demonstrated the efficacy of Pradaxa in this indication, with the drug showing significant benefits over warfarin.

The US Food and Drug Administration approved Pradaxa for this patient group earlier this month.

Professor Klaus Dugi, chief medical officer at Boehringer Ingelheim, said: "We aim to offer physicians and patients a new, simple treatment option that is as effective as warfarin, the current standard of care, while providing a favourable overall safety profile."

The drug is also used for stroke prevention in patients with atrial fibrillation and has now been approved for sale in more than 100 countries worldwide.

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