Pradaxa

FDA committee backs Pradaxa

pharmafile | September 23, 2010 | News story | Sales and Marketing Boehringer, Pradaxa, atrial fibrilation 

An FDA committee has voted unanimously in favour of approving Pradaxa for stroke prevention in patients with atrial fibrillation.

The Cardiovascular and Renal Drugs Advisory Committee’s 9 to 0 vote in favour of Pradaxa (dabigatran etexilate) will provide a major lift for Boehringer Ingelheim’s drug.

Atrial fibrillation (AF) is becoming one of the industry’s most hotly contested therapy areas, with a number of new treatments competing to gain approval to treat the often deadly condition.

Vitamin K antagonists such as warfarin have been the standard therapeutic option for AF for decades, but these require frequent checks and dose adjustments to prevent bleeding in patients.

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Pradaxa promises to protect patients against AF and associated stroke without the need for such checks. The FDA committee was persuaded by the evidence presented in the company’s RE-LY study.

Sanofi-Aventis’ Multaq (dronedarone) gained FDA approved to treat atrial fibrillation in July 2009, which puts it in pole position in the market.

Pradaxa is already approved for prevention of venous thromboembolism (VTE) in patients following elective knee replacement or hip surgery.

Other competitors in the market are Bayer’s Xarelto (rivaroxaban) and Pfizer’s apixaban, which is due to submitted to regulators within the next few months.

Andrew McConaghie

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