Important note: Information in this article was accurate in 1996. The state of the art may have changed since the publication date.
Chicago Tribune (CT) - SATURDAY, March 2, 1996 Edition: NORTH SPORTS FINAL Section: BUSINESS Page: 1 Word Count: 284
Chuck Hutchcraft, Tribune Staff Writer. Tribune wires contributed to this story.
Approval of ritonavir, which has been shown to prolong, at least slightly, the lives of severely ill patients, came with record speed.
But a spokesman for Abbott downplayed any gains for the North Chicago-based pharmaceutical giant, stressing instead the importance to AIDS patients. "It's important for them to have another weapon in their arsenal," a drug that has been shown effective in clinical tests, said spokesman Douglas Petkus.
Ritonavir--to be marketed as Norvir--becomes the second in a new class of drugs called protease inhibitors that kill HIV in a different manner than most AIDS medicines sold.
The approval came in a record 72 days, and less than 24 hours after outside advisers told the FDA the drug should be sold for advanced patients. But that panel also said Abbott should prove its effect in healthier HIV-infected people.
Also Friday, the same panel recommended approval of a third protease inhibitor, Merck & Co.'s indinavir, after hearing evidence that the drug virtually wiped HIV out of blood cells of at least 40 percent of the patients taking it.
Abbott has not announced the price of its drug, but the first protease inhibitor, Hoffman LaRoche's saquinavir, approved in December, costs $5,800 a year.
Other drugs often are prescribed in combination, and the standard among them, AZT, costs $2,300 a year.
Petkus said the drug would be in pharmacies within two weeks.
FDA Commissioner David Kessler pledged to be ready to approve indinavir when Merck has supplies ready to ship. Merck said that would be by early April.
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