Boeh Ing's Actilyse gets nod from NICE

German drugmaker Boehringer Ingelheim says that a new clinical appraisal published by the UK's National Institute for Health and Clinical Excellence (NICE) has recommended the use of its product Actilyse (alteplase) for acute ischemic stroke, based on its clinical and cost effectiveness compared with best supportive care alone.

According to the appraisal, the agent demonstrated efficacy for the condition within a time-window of three hours post stroke based on a series of randomized controlled trials that included more than 2,800 patients. These studies showed that Actilyse resulted in significantly better outcomes for patients in terms of death and dependency at three months compared with placebo.

In particular, the NICE appraisal committee noted that, in the recently-published SITS-MOST trial, mortality rates following treatment were even lower in routine practice than had previously been seen in randomized trials (11.3% versus 17.3%), while the incidence of symptomatic hemorrhages and of functional independence at three months were comparable to those in randomized controlled trials.