Activase regulatory update

The U.K.'s NICE issued a final appraisal determination (FAD) to update its previous recommendation on the use of Actilyse alteplase to treat acute ischemic stroke. Specifically, the guidance recommends the use of Actilyse within 4.5 hours of the onset of symptoms after intracranial haemorrhage has been excluded, instead of within 3 hours of the onset of symptoms. Final guidance is expected in November.

NICE said the update was due to a change in the Actilyse's labeling. Last November, Boehringer Ingelheim said Actilyse was approved under the EU Mutual Recognition Procedure in 15 European countries to treat acute ischemic stroke up to 4.5 hours after onset of stroke symptoms and after prior exclusion of intracranial hemorrhage (see BioCentury, Nov. 14, 2011). Previously, the drug was approved to treat acute ischemic stroke within a 3 hour window of onset of symptoms. ...