THE VIRGINIAN-PILOT
Copyright (c) 1996, Landmark Communications, Inc.
DATE: Saturday, March 2, 1996 TAG: 9603020280
SECTION: FRONT PAGE: A2 EDITION: FINAL
SOURCE: LOS ANGELES TIMES
DATELINE: WASHINGTON LENGTH: Medium: 52 lines
Moving with unusual speed, the Food and Drug Administration announced Friday full approval of a powerful new AIDS drug that has been shown to reduce episodes of illness and prolong the lives of very sick patients.
The licensing of ritonavir comes a scant 24 hours after an FDA advisory committee recommended that the drug be approved for use only in advanced cases of the disease.
The FDA, going beyond the committee's advice, extended its approval to much broader uses, to include patients in the early stages of infection. The expansion is contingent on the manufacturer's agreement to conduct further research in this population.
The drug, developed by Abbott Laboratories, is one of a new class of potent anti-viral drugs called protease inhibitors, which scientists believe are many times more potent than the drugs that have been in widespread use for nearly a decade.
In other action, the advisory panel recommended that a third protease inhibitor be approved for marketing. The drug, indinavir, also known as Crixivan, made by Merck & Co., has been shown in recent research to suppress the AIDS virus to undetectable levels in patients after six months and even longer when used in combination with established AIDS therapies. The first of this family, saquinavir, made by Hoffmann-LaRoche Inc., was approved by the FDA in December.
The approval of ritonavir was the fastest approval of any AIDS drug so far - 72 days - and could be the fastest drug approval in FDA history. The FDA has been criticized by the Republican Congress for its sluggish pace of drug and device approval, although in recent years the agency has streamlined its procedures to speed approval of drugs for life-threatening conditions such as AIDS and cancer.
Also Friday, President Clinton asked Congress to appropriate an additional $52 million in funds to help AIDS patients pay for drug treatment. As the approach to treating AIDS moves toward prescribing several drugs in combination, concern has mounted over their cost. Each of these drugs can cost several thousand dollars a year.
Ritonavir, which will be marketed under the name Norvir, will be available within two weeks, although its price has not yet been determined.
KEYWORDS: AIDS FDA DRUG by CNB