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NICE stroke guidance boost for Boehringer's Actilyse

Institute changes guidance on alteplase use

More people suffering a stroke in the UK should get treatment with Boehringer Ingelheim's thrombolytic drug Actilyse in the wake of new NICE recommendations.

The clot-dissolving therapy has been used by the NHS for years as an early intervention in acute ischaemic stroke patients, and it remains the only approved drug to treat them. 

Until now Actilyse (alteplase) was indicated for use in patients between three and 4.5 hours of the onset of symptoms, but the new NICE final guidance gives a green light for the drug to be given at any time in the first 4.5-hour period.

"This will give more patients access to thrombolytic therapy, though it remains crucial that doctors treat stroke patients as early as possible," said Boehringer in a statement.

NICE's guidance notes that treatment with Boehringer's drug should only be given after intracranial haemorrhage - where the stroke is a result of a ruptured blood vessel rather than a blood clot - has been excluded by appropriate imaging techniques.

Ischaemic strokes account for around 80 per cent of the 130,000 cases of stroke which occur in England and Wales each year, according to the Stroke Association charity.

Actilyse is a recombinant form of tissue plasminogen activator (TPA), a substance whose role in the body is to remove small clots that routinely form in the blood stream.

Originally developed by Roche subsidiary Genentech, which sells it in the US and Canada as Activase, the drug was first approved for use in acute ischaemic stroke in the mid -1990s. 

A green light to extend the window for treatment was granted in Europe last year, after a pooled analysis from already-completed studies showed that patients treated with Actilyse within the first three hours of symptom onset were 30 per cent more likely to have minimal or no disability three months later, compared to patients not treated with thrombolysis.

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