Pradaxa approved by NICE
pharmafile | September 26, 2008 | News story | Sales and Marketing | NICE, Pradaxa, clot, cv
NICE has recommended Boehringer Ingelheim's novel anti-clotting pill Pradaxa, giving it a marketing edge over Bayer's rival treatment Xarelto.
Pradaxa was backed as a treatment option for the prevention of venous thrombembolic events (VTE) in adults who have undergone hip or total knee replacement surgery.
It was licensed in this indication by European regulators earlier this year, when it become the first oral anticoagulant for preventing VTE to be approved in the UK for over 50 years.
Boehringer Ingelheim UK's head of medical and scientific affairs Dr Sheuli Porkess said: "We are very pleased that this decision from NICE brings this a step closer – particularly so swiftly after European marketing authorisation in March 2008.
"As a novel oral once daily anticoagulant, Pradaxa has the potential to improve patient care post hip and knee replacement surgery."
Pradaxa and Xarelto are both predicted to become blockbusters, earning in excess of $1 billion a year, but Pradaxa continues to enjoy a period of market exclusivity – and now a positive NICE recommendation – over its competitor.
Bayer is still waiting for full regulatory approval of Xarelto in Europe – only then can its cost and clinical effectiveness be assessed by NICE.
Currently the standard treatment for VTE is Clexane, Sanofi-Aventis' once-daily injection, but the two new oral drugs could prove a huge boost to patients.
Patient group AntiCoagulation Europe (ACE) welcomed NICE's decision and said oral treatments were major advance to improving compliance.
Executive Director Eve Knight said: "An oral anticoagulant that does not require anticoagulation monitoring is a major advance and will enable patients to continue with important preventative therapy after surgery and hospital discharge for the full guideline-recommended duration, without the need for injections."
But the potential blockbuster status of both Pradaxa and Xarelto will depend on extending their licenses into further indications, and in convincing doctors they are safe.
Drug safety is a key issue in the field after the 2006 withdrawal of AstraZeneca's VTE treatment Exanta (ximelagatran) due to concerns over side effects. Exanta was a first-in-class direct thrombin inhibitor in the same class as Pradaxa.
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