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EU Approves Pfizer’s New HIV Drug

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Pfizer received approval from the European Commission (EC) for Celsentri (maraviroc) for treatment-experienced HIV patients. Maraviroc, in combination with other antiretroviral medicinal products, is indicated for treatment-experienced adult patients infected with only CCR5-tropic HIV-1 virus detectable.

Maraviroc is the first of a new class of oral HIV medicines that works by blocking viral entry into human cells rather than fighting HIV inside white blood cells. Maraviroc prevents the virus from entering white blood cells by blocking its predominant entry route, the CCR5 co-receptor.

The approval is based on the following data from two ongoing double-blind, placebo-controlled trials that show: Maraviroc and optimized background therapy (OBT) provided greater viral load reduction compared to patients receiving OBT alone; twice as many patients receiving maraviroc plus OBT achieved undetectable viral load at 48 weeks; and the maraviroc and OBT group demonstrated greater increases in CD4 white cells compared to the group receiving OBT alone.

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