NICE approves Bayer’s Xarelto
pharmafile | April 23, 2009 | News story | Research and Development | Bayer, NICE, Xarelto
NICE has approved Bayer's anti-clotting treatment Xarelto, bringing it into line with Boehringer Ingelheim's rival Pradaxa.
Xarelto (rivaroxaban) was assessed under NICE's rapid single technology appraisal work programme and found to be a cost effective option for preventing blood clots.
The drug was launched in the UK last year and Bayer predicts it could reach blockbuster status with sales of more than 2 billion euros ($2.8 billion).
Both Xarelto and Pradaxa are indicated for the prevention of venous thrombembolic events (VTE) in adults who have undergone hip or knee replacements.
Boehringer Ingelheim's Pradaxa (dabigatran), the first oral anticoagulant for preventing VTE to be approved in the UK for more than half a century, got the green light from NICE last year.
Both companies say their drugs will be "revolutionary" treatments for blood clots and their approval is a major boost for patients.
They are seen as far more convenient than warfarin or Sanofi-Aventis' injectable formulation Clexane (enoxaparin), which is the most widely used treatment option at present.
NICE's decision on Xarelto was based partly on the results of trials pitting it against Clexane and Pradaxa.
The global RECORD clinical trial programme involved more than 12,500 patients in four phase III studies.
Bayer says these trials show it to be more effective than Clexane in helping to prevent unnecessary deaths, with patients at a significantly lower risk of developing blood clots while maintaining comparable rates of bleeding.
Safety has been a major issue since the withdrawal of AstraZeneca's VTE treatment Exanta (ximelagatran) in 2006 following concerns over its side effects.
In the same class of oral direct thrombin inhibitors, Exanta had also been tipped for blockbuster status with estimated peak sales of $2-3 billion.
Nearly half the recipients of the UK's 160,000 annual hip and knee replacement operations would develop a blood clot without preventative treatment.
Thrombosis charity Lifeblood says the cost to the NHS of treating patients who develop hospital-acquired DVT from all causes is thought to be as high as £222.8 million per year. By comparison the MRSA superbug costs £45 million.
Xarelto is also due to be studied in VTE treatment, stroke prevention in patients with atrial fibrillation, VTE prevention in hospitalised patients and secondary prevention of acute coronary syndrome.
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