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.