The Food and Drug Administration on Thursday formally approved the first of a new generation of powerful AIDS drugs, a family of compounds that appears at least 10 times more potent than the existing most widely prescribed antiviral therapies.
The agency’s approval of the first of those drugs, saquinavir, came in record time, only three months after the company applied for licensing and one month after an FDA advisory committee urged the agency to send it to the market.
Saquinavir is from a new group of antiviral AIDS drugs known as protease inhibitors. AIDS researchers have been very excited about the potential offered by the drugs, particularly when they are used in combination with other AIDS drugs known as nucleoside analogs. The latter include the commonly used AZT, DDI, DDC, D4T, and the recently approved 3TC.
Saquinavir is made by Roche Laboratories of Nutley, N.J., and will be manufactured under the trade name Invirase.
The FDA emphasized the swiftness of its decision to OK the drug, with FDA Commissioner David A. Kessler calling it the “is the fastest approval of any AIDS drug so far, and demonstrates FDA’s flexibility in situations when saving time can mean saving lives.”
The agency has been under attack from conservative groups and members of Congress for failing to deliver promising life-saving therapies to the public as quickly as its foreign counterparts.
In the case of AIDS drugs, the United States has acted far more rapidly than the European nations.
Three out of the six major AIDS drugs on the market here are not yet available in Europe.