Pfizer's Celsentri Approved in the European Union

Pfizer Incorporated, the world's largest research-based pharmaceutical company today got the European Commission (EC) approval for Celsentri, its new oral AIDS drug.

Generically known as Maraviroc, Celsentri is the first in a new class of oral HIV medicines to be introduced in more than a decade.

To be used in combination with other antiretroviral medicinal products, Maraviroc can only treat patients infected with CCR5-tropic HIV-1 virus. Not all HIV patients are diagnosed to be infected with the R5 virus. The virus causes patients to become resistant to other treatments.

Unlike conventional HIV treatments that fight the AIDS virus inside white blood cells, the new drug when used, keeps the HIV virus that causes AIDS from invading the healthy immune cells.

“Maraviroc is an important additional treatment option for R5 tropic treatment-experienced patients in Europe,” noted Gerd Faetkenheuer, MD, Department of Internal Medicine, University of Cologne, Germany.

“Although other treatments are currently available, maraviroc targets the fight against the HIV virus in a new way.”

“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”, explained Pfizer’s scientists.

Maraviroc, known as Selzentry in the United States, was approved by the U.S. Food and Drug Administration (FDA) on August 6, 2007 and is currently available in the United States.

Though undergoing clinical trials as of early 2007, the European Commission approval of maraviroc is based on a 48 week data collected from the two ongoing double-blind, placebo-controlled MOTIVATE clinical trials.

The drug trials revealed that patients receiving a combination of both Maraviroc and optimized background therapy (OBT) provided higher viral load reduction compared to patients receiving OBT alone.

An undetectable viral load at 48 weeks was observed in more than twice as many patients receiving Maraviroc plus optimized background therapy (OBT) as compared to those receiving OBT alone.

The patients received both treatments also reported a significantly greater increases in CD4 white cells compared to the group receiving OBT alone. However, both groups demonstrated similar discontinuation rates of 3.8 percent.

First recognized in 1981, the AIDS virus has killed more than 25 million people world over since then.

Founded in 1849 with headquarters at New York City, the company is the producer of number-one selling drugs like Lipitor - used to lower blood cholesterol, Diflucan - an oral antifungal medication and erectile dysfunction drug Viagra among others.

Holding high hopes from Maraviroc, Pfizer expects to generate annual sales of $500 million by 2011 from the drug.