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Boehringer’s Pradaxa wins FDA backing for DVT

 Anticoagulant sees uses expanded in the US

Boehringer Ingelheim Pradaxa dabigatran pack 

Boehringer Ingelheim has won another blood clot approval for its oral anticoagulant Pradaxa in the US.

The FDA gave the green light for use of the anticoagulant in the treatment and reduction in risk of recurrent deep vein thrombosis (DVT) and pulmonary embolism (PE).

The approval covers the use of Pradaxa (dabigatran etexilate) in patients who have been treated with an injectable anticoagulant, such as heparin, for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated.

This adds to existing approval for use in the prevention of stroke in patients with atrial fibrillation and opens up an important new market for Pradaxa, which is emerging as one of Boehringer's most significant new treatments.

Gaining this indication in DVT and PE also allows Pradaxa to close the gap on its main rivals in the new generation of oral bloodthinners: Bayer and Johnson & Johnsons's Xarelto (rivaroxaban) and Pfizer and Bristol-Myers Squibb's Eliquis (apixaban).

Xarelto won FDA approval in November 2012 for use in the treatment and prevention of DVT and PE, and has stolen a march on its competitors, breaking into the top 50 best-selling medicines for 2013, as seen in PMLiVE's Top Pharma List.

Eliquis lags a little behind, having only won FDA approval to treat DVT and PE in patients undergoing hip and knee surgery last month, although Pfizer and BMS are looking to expand this DVT and PE indication further to match that of Xarelto and, now, Pradaxa.

All drugs have shown effectiveness in treating blood clots and doctors have welcomed them as simpler, safer alternatives to the standard therapy warfarin, which requires constant monitoring and has several serious side effects.

Pradaxa's particular approval in DVT and PE is based on data from four phase III clinical trials involving almost 10,000 patients that demonstrated a 92 per cent reduction in the risk of recurrent blood clots versus placebo.

Despite Xarelto's earlier approval, Boehringer commented that Pradaxa's simpler dosing regimen could give the drug an edge in treating DVT and PE.

Whereas Xarelto is recommended at a dose of 15mg twice-daily for three weeks, followed by 20mg once daily for the remaining treatment period, Pradaxa is recommended at a standard 150mg twice-daily dose throughout treatment.

Article by
Thomas Meek

9th April 2014

From: Sales



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