FDA OKs First in New Batch of AIDS Drugs

The Food and Drug Administration on Thursday formally approved the first of a new generation of powerful AIDS drugs, a family of compounds that appear 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 excited about the potential offered by the drugs, particularly when they are used in combination with other AIDS drugs known as nucleoside analogs.

Saquinavir is made by Roche Laboratories of Nutley, N.J., and will be manufactured under the trade name Invirase. Roche officials said that the drug would be on pharmacy shelves within 48 hours. The company said that the wholesale price of a daily dose will be $15.89.