Genentech Clot-Dissolving Drug Gets Federal Approval

Genentech Inc. won approval from the Food and Drug Administration to market the first drug that could protect stroke victims from permanent brain injury, but only if they get to an emergency room fast.

Genentech’s clot-dissolving drug tPA, sold under the brand name Activase, is widely used to treat heart attacks. Some stroke specialists already were giving it to their patients as well.

The new FDA approval means South San Francisco-based Genentech can advertise tPA to emergency rooms, rural doctors, even patients, educating them to recognize the earliest signs of strokes and get help within the three-hour window during which tPA can work.

Federal health officials called the approval a landmark event.

Researchers, in clinical trials conducted by the National Institutes of Health, found that Activase, when given within three hours of a stroke, could help stave off the debilitating side effects of the condition, 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.

Genentech’s shares fell 12.5 cents to close at $53.125 Tuesday on the New York Stock Exchange.

Though analysts estimated the new therapy may add only a small percentage to the more than $300 million in annual sales for Activase, the federal approval 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.”

The FDA sounded a cautionary note about Activase, noting that it can have deadly effects if not used carefully by doctors.

Treatment that begins later than three hours after a stroke’s onset can trigger dangerous bleeding in the brain.

Stroke afflicts about 500,000 Americans each year and is the third leading cause of death in the U.S., claiming the lives of about 150,000 Americans each year. The condition often causes lasting brain damage that can lead to paralysis.