The MHRA has reconfirmed that the benefits of Boehringer Ingelheim’s controversial stroke drug Actilyse outweigh its risks in a new review.

Actilyse (alteplase) is commonly used to break down blood clots in ischaemic stroke patients and reduce the chance of long-term disability. However, it also carries an increased risk of dangerous bleeding in the brain.

The drug was originally recommend because the chances of improved recovery were thought to outweigh this risk. But the MHRA set up an expert working group to reassess the drug after specialists raised concerns about the strength of the evidence this was based on.

The new review concluded that the latest available data show that the benefits of Actilyse do indeed outweigh its risks when used up to 4.5 after the onset of symptoms – but the working group noted that the benefit is highly time dependent, and minimising the time to the start of the treatment is critical.

“Patients, the public and healthcare professionals should be reassured that the independent expert working group has rigorously reviewed and discussed all available data and unanimously concluded that alteplase remains safe and effective for use in the treatment of acute ischaemic stroke,” says Professor Sir Ian Weller, who chaired the group.

“The evidence shows that for every 100 patients treated with alteplase, whilst there is an early risk of a fatal bleed in two patients, after three to six months, around 10 more in every 100 are disability-free when treated within three hours. In addition five more patients in every 100 are disability free when treated between three and 4.5 hours after a stroke.

“The conclusion of the group is very clear in that the current time-frame for treatment is supported by strong evidence.”