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FDA approves AIDS drug in record time

March 1, 1996
Web posted at: 11:10 p.m. EST

WASHINGTON (CNN) -- The Food and Drug Administration Friday agreed to make a promising new AIDS drug available to patients with advanced HIV infections less than 24 hours after a panel of outside advisors recommended it.

The drug, ritonavir, has been shown to prolong, at least slightly, the lives of severely ill patients.

An FDA advisory committee recommended approval of ritonavir, manufactured by Abbot Laboratories Inc., as well as indinavir, manufactured by Merck and Co. The FDA called the data on indinavir "very compelling" and said its review would be ready by the time Merck is ready to ship the drug to pharmacies in early April.


The two drugs are protease inhibitors and were widely publicized at a government sponsored-conference on viruses earlier this year.

Abbot, which said the drug would be on pharmacy shelves within two weeks, has not announced its price. The first protease inhibitor, Hoffman LaRoche's saquinavir, approved in December, costs $5,800 a year.

Doctors warned that ritonavir interacts dangerously with other common medicines, from heart drugs to allergy relievers. Abbott will give patients a wallet-size card that lists 23 medicines to avoid when taking ritonavir, which will be sold under the brand name Norvir.


Protease inhibitors kill HIV by crippling an enzyme crucial to the survival of the virus, a different mechanism than most AIDS drugs.

Merck's drug has been at the FDA just 29 days and isn't as far along as ritonavir in the FDA's evaluation process. If approved, the drug will be sold under the brand name Crixivan.

The AIDS community recently has pressured the FDA for speedier drug approval. Many patients are already taking protease inhibitors under experimental programs.

AIDS drugs in general have been on the fast track, and the FDA has been willing to approve them with the understanding that if experience with patients shows the drugs to be unsafe or ineffective, they could be recalled.

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