Boehringer boost as MHRA confirms benefit of stroke drug alteplase

Boehringer Ingelheim (BI) is celebrating after an independent evaluation in the UK has reconfirmed that the benefits of its clot-busting drug alteplase outweigh the risks for acute ischaemic stroke.

An eagerly-awaited expert working group review, on behalf of the Medicines and Healthcare products Regulatory Agency (MHRA), has been completed and concludes that alteplase, sold as Actilyse 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'.

Good news, then, for BI and alteplase, which was the subject of a BBC programme last month in which claims were made that the drug should be suspended from routine use. During the 'File on 4' radio programme, Roger Shinton, referred to as a former stroke physician at Birmingham's Heartlands Hospital, was quoted as saying, "it may be that on balance the number of people benefiting is actually quite small and does not justify the use given the significant harms that we know."

This claim was met with bemusement by stroke experts. At the time the BBC programme was broadcast, Joanna Wardlaw, chair of applied neuroimaging at Edinburgh, who has published over 400 papers in this field, told pharmaphorum, "there are no stroke experts that I know of who think use of alteplase should be stopped/reviewed/curtailed – quite the opposite."

She added that "the data are overwhelming that it is beneficial, especially if given early. All of the questions have been raised by non-experts in stroke or thrombolysis – ie emergency room physicians, economists, non-medics and non-stroke doctors."

The MHRA Expert Working Group (EWG) agrees with Prof Wardlaw and Sir Ian Weller, who chaired the review, said the group "has rigorously reviewed and discussed all available data and unanimously concluded that alteplase remains safe and effective." He noted that 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."

Prof Weller added that 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," he concluded.

Charles De Wet, medical director for BI in the UK and Ireland, said, "our medicine is the only licensed clot buster for acute ischaemic stroke, the shockwaves of which can leave a lasting and profound impact on how people move, see, speak, feel or understand their world." He added that the news from the MHRA EWG "confirms that our medicine can play a vital role in improving the lives of patients."