MHRA review supports use of Actilyse (alteplase) in treatment of Stroke-Boehringer

An expert working group review, on behalf of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, has been completed and concludes that alteplase, sold as Actilyse by Boehringer in the UK, is safe and highly effective when used in accordance with the product licence � i.e. up to 4.5 hours after symptom onset.

The MHRA stressed that the benefit of alteplase 'is highly time-dependent and therefore minimising the time to onset of treatment is critical to ensuring the best possible outcome'. 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.Five more patients in every 100 are disability-free when treated between three and 4.5 hours after a stroke.