Activase Gains Backing For Stroke Indication

Genentech has won a recommendation for approval to market Activase (alteplase) for a new indication, the treatment of acute ischemic stroke, in the USA.

The Food and Drug Administration's Peripheral & Central Nervous System Drugs Advisory Committee voted unanimously that Activase should be approved for treatment of stroke, provided patients present early enough so that the drug can be given within three hours of onset of symptoms. Furthermore, the panel said that patients should not show any evidence of intracranial bleeding on a computed tomography scan given prior to treatment.

The application to extend Activase's indications to include stroke was made on the basis of Phase III data from a National Institute of Neurological Disorders & Stroke (NINDS) study, published in the New England Journal of Medicine at the end of last year (Marketletter January 1 and 8), which revealed that the drug was effective in improving neurological function scores compared to placebo when given within this narrow time window. Activase is already approved to treat myocardial infarction and acute massive pulmonary embolism.