Exanta ready for launch across Europe
pharmafile | January 7, 2004 | News story | |
AstraZeneca's new blockbuster candidate Exanta has been approved in France for the prevention of blood clots in major orthopaedic surgery.
The approval is the first in the world for the drug which is the first new treatment in the direct thrombin inhibitor class for almost 60 years, and paves the way for its launch across Europe under the mutual recognition procedure.
AstraZeneca is also seeking two additional licences in the US and Europe – the first for the prevention of stroke and the other for thromboembolic complications associated with atrial fibrillation as well as for the long-term secondary prevention of venous thromboembolism after standard treatment following an episode of acute VTE.
Analysts estimate that the drug could generate peak sales of $3 billion a year, with its stroke prevention abilities promising to deliver the majority of these sales.
Current standard anti-clotting treatment warfarin requires regular checks to avoid haemorrhaging and liver damage but Exanta requires far fewer, offering a more convenient medication for doctors and patients.
Rival products include Aventis' Lovenox (known as Clexane in the UK) and Sanofi-Synthelabos Arixtra, which recently gained a licence to prevent blood clots after hip fractures and knee surgery.
Exanta has the advantage over these injected products because of its more patient-friendly oral formulation. A spokesman also confirmed that there would be no requirement to monitor Exanta's use following knee and hip surgery, but said regulators may demand liver monitoring for long-term use in the prevention of strokes.
"Exanta offers a fundamentally new approach to prevention of thrombosis, one of the largest causes of morbidity and mortality in the western world," commented Dr Hamish Cameron, vice president, Head of Exanta, AstraZeneca. "We are pleased to announce this approval as the first step in introducing this innovative new anticoagulant to patients."
In the UK, the drug was identified through NHS 'horizon scanning' as one which could alter prescribing behaviour and increase spending significantly, with NICE announcing in October that it would be appraised. The Institute now anticipates publishing its guidance on the drug in its stroke prevention indication in February 2005 allowing AstraZeneca some time to generate further clinical and cost effectiveness data.
Meanwhile a separate NICE appraisal of Aventis' Tritace, which is licenced for the prevention of strokes, as well as other products in the ACE inhibitor class is also to be conducted, although its timing is yet to be confirmed.
