Alteplase regulatory update

Roche disclosed in its 2Q12 earnings that it withdrew an sBLA to expand the label for Activase alteplase to extend the time window for treatment of acute ischemic stroke (AIS) to 4.5 hours. Activase is currently approved to treat AIS within 3 hours after stroke symptom onset. Roche said it made the decision after receiving a complete response letter from FDA for the application. According to the pharma, FDA said data from Boehringer Ingelheim's double-blind, international Phase III ECASS III trial was "not sufficiently compelling" to support the label expansion. In the trial, alteplase significantly improved clinical outcome at day 90 vs. placebo when treated 3.0 to 4.5 hours after onset (52% vs. 45%, p=0.04) (see BioCentury, Oct. 6, 2008). Roche said its Genentech unit is working to determine appropriate next steps. ...