On the 5^th September 2007, fast-tracked approval was overwhelmingly recommended by the US Food and Drug Administration for a newly-developed AIDS treatment. The drug is aimed at the expanding amount of AIDS patients on whom previous treatments have so far failed. Entitled Isentress, the drug is manufactured by Merck & Co. It stands as the first such treatment developed in a class of drugs called integrase inhibitors, designed to stop AIDS from interacting with human cell DNA.

Last month, the US FDA's advisory panel approved Selzentry - Pfizer's innovative new drug within the CCR5 inhibitor classification. In reference to the new wave of drugs now available for AIDs patients, the University of California's Dr Richard Haubrich recently said: "I think we have kind of come to another milestone in the treatment of HIV."

His comments were echoed by Jeff Bailey, who stated: "Any time a new option comes up for persons living with HIV that demonstrates efficacy, is relatively easy to tolerate with few side effects -- that's definitely cause for excitement." Mr Bailey works at AIDS Project Los Angeles, where he is the Director of Client Services.

A certain percentage of the US FDA's advisory panel highlighted the fears over reports of Isentress inducing abnormal growths of tissue and cancers in some patients. However, according to both Merck, and members of the FDA itself, the rate at these were recorded was equivalent to that known in patients harbouring a virus which drugs could not affect. As per one of the panel involved in the approval recommendation, Dr Marshall Glesby: "Overall, based on the data we've seen today, the risk-to-benefit ratio seems fairly favourable."

The data causing the cancer-risk concern came from three trials recently conducted, in which approximately 900 patients participated. Two thirds of these were administered Isentress, which they took in tandem with a mixture of alternative AIDS treatments. Malignancies subsequently grew in 13 of this group. The remaining 282 patients took regimen, alongside a placebo, and no cancerous side effects were noted in them.

Post-trial, a review was carried out by the US FDA. In this, the fact that the Isentress group had, in some cases, developed these malignancies, while nobody within the placebo group had, was put down to apparent chance. In fact, the lower-numbered group produced a lower-than-anticipated number of side effects.

In a separate assessment, Isentress reduced the concentration of the AIDS virus to a level where it could no longer be detected in 62 per cent of a group of 700 patients. The comparable figure for those purely using a placebo was around 34 per cent.

Isentress is now expected to gain full approval by around Spring 2008. Although the US FDA is not obliged to act on the recommendations given by its panel, historically, it has been seen to follow its advice on many occasions.

Source - Pharmaceutical International's Research and Development Analyst

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