FDA Approves First Drug In USA For Ischemic Stroke

Just days after receiving the backing of a Food and Drug Administration advisory panel, Genentech's tissue plasminogen activator Activase (alteplase) has been approved for the treatment of acute ischemic stroke in the USA, and becomes the first drug cleared there to treat the condition, which is the leading cause of adult disability in the developed world.

The extension of Activase's indications came about as a result of good data from the National Institute of Neurological Disorders and Stroke trial, which was published in the New England Journal of Medicine on December 14, 1995. This found that, provided stroke patients receive Activase treatment within three hours of symptom onset, more patients had minimal or no disability at three months compared to a placebo group.

Activase is not appropriate for hemorrhagic stroke patients, and not all ischemic patients will meet the criteria for Activase therapy. For example, patients with evidence of recent or active bleeding (found using a CT scan), recent stroke, uncontrolled high blood pressure or impaired blood clotting should not be treated with Activase. The most common serious side effect from this therapy is intracranial hemorrhage, but there was no significant mortality difference between the Activase and placebo groups at three months.