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FDA Grants Accelerated Approval To Third Protease Inhibitor To Treat HIV

Date: March 14, 1996
Source: Food and Drug Administration (FDA)

The Food and Drug Administration announced today it has granted accelerated approval to the third in a new class of AIDS drugs called protease inhibitors. Indinavir, the new drug, received accelerated approval late yesterday for use alone or in combination with nucleoside analogue medications, such as AZT, in people with HIV or AIDS. FDA approved the drug just 42 days after receiving its application for its marketing.

The Clinton Administration is committed to the fight against AIDS, including the President's ultimate goal of a cure for this disease," said HHS Secretary Donna E. Shalala. "Rapid FDA action on important new drugs is one important part in reaching the long-term goal."

The pharmaceutical companies that have led the development of protease inhibitors deserve a lot of credit," said Commissioner of Food and Drugs David A. Kessler, M.D. "It's been an historic period in the fight against AIDS. This accelerated approval -- a new record for the agency -- is further confirmation of our commitment in the fight."

FDA based its approval for indinavir on data showing that the drug improves laboratory markers, such as CD4 counts, an indication of immune system strength, and viral load, a measure of the amount of virus that can be detected in the bloodstream.

In clinical studies, indinavir was studied alone and in combination with nucleoside analogues in HIV-infected people in various stages of disease. Each of these trials monitored changes in participants' CD4 cell counts and viral load.

These results were shown primarily in two controlled clinical trials involving a total of 490 patients. The trials studied one group receiving indinavir alone, another group receiving the drug in combination with AZT, and a third group treated with just AZT.

FDA also reviewed data from a small study that evaluated the progress of 96 patients using indinavir in combination with two nucleoside analogues, AZT and 3TC.

Clinical data indicated that patients receiving indinavir alone or in combination with nucleoside analogues experienced a marked increase in their CD4 levels and had a marked decrease in their viral load.

FDA grants accelerated approval, a regulatory mechanism that allows for early marketing approval for a product based on laboratory markers, with the understanding that the drug sponsor must eventually demonstrate that the product provides true clinical benefit with endpoints such as extended life span or slower disease progression. Otherwise, the agency may withdraw the granted accelerated approval. Two trials are ongoing to evaluate the clinical benefits of indinavir.

Among the major adverse events reported with indinavir therapy were infrequent kidney stones and frequent increases in bile production.

Indinavir is manufactured by Merck & Co. Inc. under the trade name CrixivanTM.