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Exanta on NICE list ahead of marketing authorisation

Published on 29/10/03 at 10:25am

AstraZeneca's Exanta is to be in NICE's next programme of appraisals even though the blood-thinning drug has not yet received UK regulatory approval.

The inclusion of Exanta (ximelagatran) on the new list of appraisals referred to NICE is a sign of an increasingly forward-looking agenda meant to free innovative products from so-called 'NICE blight'.This sums up the uncertainty among NHS prescribers when NICE is conducting a trial, with many physicians deterred from starting patients on a drug before the Institute issues its verdict.

But NICE appraisals which try to preempt marketing authorisation also face difficulties over the confidentiality of data - while NICE is committed to transparency, companies do not want commercially sensitive data published before a licence is issued.

NICE and the ABPI are now understood to be just days away from announcing a new concord on how to satisfy the requirements of both sides, having built on government proposals to consult more fully over the timing and selection of NICE topics.

Exanta will be appraised for its clinical and cost-effectiveness in two indications - treating venous thrombo-embolism and the prevention of stroke in patients with atrial fibrillation.

AstraZeneca say the drug is on track to be submitted for regulatory approval in the major markets later this year, with phase III trials showing promising results despite concerns over its effect on patient livers.

Also included for NICE  appraisal are Wyeth Enbrel and Schering-Plough's Remicade for ankylosing spondylitis.

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