Moving with unusual speed, the Food and Drug Administration Friday announced 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.
“This drug provides real hope for patients with AIDS,” FDA commissioner David A. Kessler said. “Patients will live longer.”
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, manufactured 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 in fact 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.
“Our national investment in AIDS research is paying off,” President Clinton said in a statement on the new drug’s approval. “Among scientists, as among many people living with HIV, despair is giving way to hope. We cannot stop now. We must recommit ourselves to finding a cure.”
Also Friday, 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.