NICE news for Boehringer’s stroke drug
pharmafile | October 12, 2012 | News story | Sales and Marketing |
Boehringer Ingelheim will be delighted with final guidance from NICE recommending that its veteran drug Actilyse be used as early as possible after the onset of ischaemic stroke symptoms.
The watchdog says patients should be treated with Actilyse (alteplase), which has been around since the late 1980s and is the only approved treatment option for thrombolytic treatment in this area, within 4.5 hours – after exclusion of intracranial haemorrhage by appropriate imaging techniques.
Early administration is cost effective in this type of stroke when a vessel is obstructed by a blood clot, as it decreases the probability of disability, death or dependence, the NICE Appraisal Committee said.
A UK marketing authorisation for the recombinant tissue plasminogen activator to be used within 3 hours of the onset of symptoms was granted in September 2002.
The new guidance, which replaces NICE’s June 2007 appraisal, comes after an extension to its marketing authorisation allowed treatment to be started from 3 to 4.5 hours after symptom onset.
Boehringer submitted data to NICE from the ECASS III trial which saw the drug administered within these times, and then sought to assess the presence or absence of disability at 90 days using the modified Rankin scale.
The trial found 52.4% of patients randomised to the alteplase arm had no significant disability at 90 days, compared with 45.2% of placebo patients.
The extended window allows more patients to be effectively treated, but Boehinger warns that early action is still crucial: “It remains necessary that patients eligible for thrombolysis are treated without delay to maximise effectiveness.”
Actilyse is approved in most of the EU for use within 4.5 hours, and first came onto the market in 1987 to treat acute myocardial infarction. Further approvals followed in acute pulmonary embolism and ischaemic stroke.
Adam Hill
