Pradaxa gets DVT indication
pharmafile | June 6, 2014 | News story | Sales and Marketing | Boehringer, DVT, Pradaxa, blood, dabigatran etexilate, thinner
Pradaxa has been given approval in Europe to treat deep vein thrombosis (DVT) and pulmonary embolism (PE) just a week after Boehringer Ingelheim paid out $650 million to settle US legal battles over the blood-thinner.
Boehringer made its settlement to bring to an end to 4,000 lawsuits which have been brought against the company in the US over Pradaxa (dabigatran etexilate).
These state and federal cases concern allegations that the drug has caused severe or fatal bleeding – a well-known complication of all anticoagulant medicines, with their ability to prevent strokes and thus save lives balanced against this side effect.
Pradaxa’s positive risk/benefit profile has been recently reconfirmed by regulators: it is one of three new oral blood-thinners – along with Bayer’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) – set to replace the 50-year old treatment warfarin.
The European Commission decision on DVT and PE patients follows a similar move by the US Food and Drug Administration earlier this year.
Almost a third of PE patients die within three months, and four out of ten suffer a repeat blood clot within ten years of the first.
Klaus Dugi, Boehringer’s chief medical officer, says: “Access to this new treatment option is critical for patients as we know that PE as a consequence of a DVT is still the leading cause of preventable death in hospital.”
The regulators based their decisions on three Phase III clinical trials that demonstrated the efficacy of Pradaxa compared with warfarin.
A fourth trial showed a 92% reduction in the risk of recurrent blood clots in patients treated with Pradaxa compared to placebo.
“Clinical trial results show that dabigatran has a favourable safety profile compared to warfarin, while offering similar efficacy for the treatment and prevention of recurrence of DVT and PE,” says Stavros Konstantinides, deputy scientific director of the centre for thrombosis and haemostasis of Johannes Gutenberg University in Mainz.
“The added benefits of convenience and a simple fixed dose regimen will appeal to patients and their physicians alike,” he adds.
Adam Hill
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