FDA urges drug co's to collaborate on testing salvage drugs

Keith Alcorn
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This article is more than 24 years old.

The US Food and Drug Administration is writing to all companies testing experimental anti-HIV drugs encouraging them to collaborate in designing `salvage therapy' studies which include more than one new drug.

In a letter posted to the FDA website on September 30, Heidi Jolson of the FDA's Office of Drug Evaluation told drug developers that `factorial' studies which can distinguish the contribution of different agents will be necessary, but that trial participants should nevertheless have the opportunity to receive several potentially active drugs.

This advice implies that new drugs like ABT-378, tenofovir, T-20 and lodenosine could be offered together in clinical trials next year if their manufacturers can agree on how they should be studied. It is thought that these drugs will be more effective in highly treatment-experienced people than any of the drugs currently available if they are used in combinations of two or more.

Glossary

salvage therapy

Any treatment regimen used after a number of earlier regimens have failed. People with HIV who have experienced side-effects and/or developed resistance to many HIV drugs receive salvage therapy, sometimes consisting of a large number of medications.

Food and Drug Administration (FDA)

Regulatory agency that evaluates and approves medicines and medical devices for safety and efficacy in the United States. The FDA regulates over-the-counter and prescription drugs, including generic drugs. The European Medicines Agency performs a similar role in the European Union.

treatment-experienced

A person who has previously taken treatment for a condition. Treatment-experienced people may have taken several different regimens before and may have a strain of HIV that is resistant to multiple drug classes.

In Europe, licensing authorities have yet to review the question of how salvage studies should be conducted.

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