Stroke treatment backed by NICE

by IainBate 26. September 2012 12:49

Pharma NICE Update NICE has recommended the use of Boehringer Ingelheim’s Actilyse (alteplase) in final guidance for the treatment of acute ischaemic stroke.

Actilyse has been recommended as an option for use on the NHS as long as it is administered as early as possible within 4.5 hours after the onset of stroke symptoms and once bleeding on the brain has been ruled out with a scan.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the benefits of Actilyse in reducing long-term disability are “well recognised”.

The UK Stroke Association estimates there are more than 130,000 people in England and Wales who have a stroke each year. Ischaemic strokes are believed to account for around 80% of all strokes.

The recommendation follows an update to Actilyse’s license which allows an extension in the time period it can be used – from three hours to within 4.5 hours of the onset of symptoms.

“Today’s guidance recommending the use of alteplase within the extended time frame for which it is now licensed has the potential to have a significant impact on the treatment of thousands of patients,” said Professor Longson.

Stroke treatment recommendation changed

by IainBate 24. August 2012 12:52

Pharma NICE Update NICE has updated its recommendation on the use of Boehringer Ingelheim’s Actilyse (alteplase) for the treatment of acute ischaemic stroke after the drug’s licence was changed.

Actilyse is now recommended in draft guidance as long as the treatment is administered as early as possible within 4.5 hours after the onset of stroke symptoms, and after intracranial haemorrhage has been excluded by appropriate action.

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said the updated recommendation has the “potential to have a significant impact” for thousands of patients.

The UK Stroke Association estimates that more than 130,000 people in England and Wales have a stroke each year. Approximately 80% of these cases are as a result of ischaemic strokes.

Actilyse was initially licensed for treatment within 3 hours of the onset of stroke symptoms. NICE acknowledged the benefits of the treatment in reducing the long-term disability caused by stroke and say its new license now fits in line with its quality standard for the condition.

Final guidance on the recommendation is now expected in November 2012.

Extended window for rapid stroke response drug

by JoelLane 16. April 2012 14:14

Pf product news Boehringer Ingelheim’s thrombolytic drug Actilyse has been given an extended indication in the UK for treatment of acute ischaemic stroke.

Actilyse (alteplase, rt-PA) can now be used to disperse cerebral blood clots within 4.5 hours after the start of stroke symptoms, rather than 3 hours as before.

The extended indication has the potential to make the drug available to nearly 5% more patients.

Actilyse is the only drug indicated for thrombolytic treatment of acute ischaemic stroke, and is used in 85 countries worldwide.

Ischaemic stroke, caused by a cerebral blood clot, is the leading cause of disability in the UK.

Rapid treatment of ischaemic stroke is essential, as every minute without treatment can lead to the death of 2 million brain cells, increasing the likelihood of disability or death.

The new indication is based on data from the European Cooperative Acute Stroke Study (ECASS 3), which showed that extending the window for treatment with Actilyse could benefit 2% more stroke patients – while an ongoing trial suggests that the number could be as high as 4.7%.

Actilyse is a genetically-engineered version of the natural tissue plasminogen activator, which removes small clots in the bloodstream.

The drug is sold outside North America and Japan by German-based company Boehringer Ingelheim.

Dr Martin James, Consultant Stroke Physician at The Royal Devon and Exeter NHS Foundation Trust, said: “Extending the licensed time window for thrombolysis treatment with alteplase to 4.5 hours from onset represents a major step forward in the treatment of acute ischaemic stroke.”

“We’re delighted to hear that the time window within which thrombolysis can be given to patients has now been increased, meaning that it will be available to more people,” commented Dr Peter Coleman, Deputy Director of Research at the Stroke Association.

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