Pfizer Awaits FDA Approval for New AIDS Drug, Maraviroc

by Savitha C Muppala on  April 24, 2007 at 3:05 PM Drug News   - G J E 4
Pfizer Awaits FDA Approval for New AIDS Drug, Maraviroc
Washington -According to the recent communiqué from US drug reviewers, the experimental AIDS drug from Pfizer Inc. promises to contain the HIV virus when used in combination with popular drugs.

The drug, in question named as maraviroc may find a prominent place amongst drugs meant for AIDS with its power to impede the CCR5 co-receptor, the main route for the entry of the virus into the cells. This drug has certainly raised its manufacturer's hopes with a projected sales forecast of $500 million in 2011.

The CCR5 inhibitors have been associated with risks such as lymphoma and liver damage, which is an area of concern. According to the FDA reviewers, Maraviroc did not alter the lymphoma in Pfizer studies, yet there was a significant increase in liver abnormalities. Animal studies also showed that maraviroc could extend the "QT interval," which may not be good for the heart. But Pfizer has reiterated that no considerable change in the QT interval was observed during the clinical trials.

According to the FDA review committee, studies showed that the treatment was successful in 45% of the patients who underwent treatment for 24 weeks as against 25% who took a placebo. All patients received a mix of the most popular and recommended drugs in use to treat HIV. The FDA reviewers have agreed with the manufacturer's analysis about the effectiveness of the drug.

The Food and Drug Administration will also address the issue of labeling and the necessity of additional clinical trials before the final decision can be taken. An FDA advisory panel comprising of outside experts will take the final decision regarding the drug, Maraviroc, for patients who have already been treated with other AIDS drugs.

Source: Medindia

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