ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Wednesday, June 19, 1996 TAG: 9606190049
SECTION: BUSINESS PAGE: B-6 EDITION: METRO
DATELINE: WASHINGTON
SOURCE: Bloomberg Business News
ACTIVASE, WHEN GIVEN within three hours of a stroke, could help stave off the debilitating side effects, including brain damage and paralysis.
Genentech Inc. won approval from the Food and Drug Administration to market its blockbuster heart drug Activase as the first emergency drug treatment for stroke.
Federal health officials called the approval a ``landmark'' event.
``From today forward, stroke must be viewed as a `brain attack,' a medically treatable, emergency condition just as critical as a heart attack,'' the National Institutes of Health and the Department of Health and Human Services said in a joint statement.
Shares in South San Francisco, Calif.-based Genentech were unchanged at 531/4 in afternoon trading.
In clinical trials conducted by the NIH, researchers found that Activase, when given within three hours of a stroke, could help stave off the debilitating side effects, including brain damage and paralysis. Before today, there were no drugs available for patients arriving in the hospital after suffering a stroke, the leading cause of adult disability.
The NIH will help launch an effort to teach health-care workers and the public about the importance of rapid treatment for stroke, said Michael Walker, director of the stroke division at the National Institute of Neurological Disorders and Stroke.
``We have a major education task ahead, but the payoff is in the tens of thousands of patients who will be spared lifelong disabilities,'' he said.
The drug is approved for treating ischemic stroke, a common stroke that occurs when there is an insufficient supply of blood to a specific organ or tissue, usually because of a blocked artery. To date, there's no effective cure.
The approval comes less than two weeks after an FDA advisory panel recommended using the drug for stroke treatment and less than three months after the company filed for FDA approval of the new use.
The advisory panel June 6 said the drug's main potential side effect, cerebral hemorrhage, is outweighed by the benefits.
``It can't be given with impunity,'' said Harold Adams, a panel member and neurology professor at the University of Iowa. ``There's no question that there's increased risk, but stroke is a bad disease.''
In clinical trials, researchers found that of every 100 patients who received the drug within 90 minutes of stroke, at least 11 recovered more completely on Activase than those receiving a placebo.
The treatment can be made available right away, the company said, because hospitals already have Activase, which has been available since 1987 for dissolving blood clots in heart attack patients. The drug is mixed at a different dosage to treat strokes.
Though analysts predicted the new indication may only add a small percentage to the more than $300 million in annual sales for Activase, also known as t-PA, the indication is nonetheless significant, they said.
``It's a very important therapy claim to get,'' said David Saks, an analyst with Gruntal & Co. ``It is life saving ... there is no drug to satisfy this need.''
Stroke afflicts about 500,000 Americans each year and is the third leading cause of death in the United States, claiming the lives of about 150,000 Americans each year. The condition often causes lasting brain damage that can lead to paralysis.
About 3 million people live with the effects of stroke, and more than a million are severely disabled.
First issued in the mid-1980s, t-PA failed to live up to forecasts of wide acceptance as a clot-buster in heart attack victims. For heart attacks, t-PA costs about $2,200 a dose, while streptokinase, which had about an equal effect in heart attack patients, costs about $200. Earlier studies did not show a significant medical difference between the two drugs.
LENGTH: Medium: 79 linesby CNB