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UPDATE 1-EU backs Pfizer HIV drug facing U.S. delay

Thu Jul 19, 2007 4:56pm EDT
 
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(New throughout, previous LONDON)

NEW YORK, July 19 (Reuters) - The scientific committee of the European Medicines Agency said on Friday it had recommended approval of Pfizer Inc.'s (PFE.N: Quote, Profile, Research, Stock Buzz) Celsentri, a new type of treatment for HIV whose approval has been delayed in the United States.

The Committee for Medicinal Products (CHMP) said it had recommended marketing approval of Celsentri, known as maraviroc in the United States, for use with other anti-HIV drugs among adult patients infected with the HIV-1 strain of the virus.

But the committee said Celsentri is meant to be used only among CCR5-tropic patients, meaning those whose HIV virus uses the CCR5 co-receptor as a portal into human cells.

Pfizer last month received a so-called approvable letter from the U.S. Food and Drug Administration for its twice-a-day maraviroc pill, the first drug designed to keep the HIV virus that causes AIDS from entering healthy cells of the immune system. Older HIV medicines attack the virus itself.

Pfizer said the FDA would approve maraviroc once certain conditions were met, but it did not specify the requirements.

The Committee for Medicinal Products on Friday said it had also recommended approval in Europe of Pfizer's Ecalta

(anidulafungin) as a treatment for invasive candidiasis in adult patients who have normal levels of infection-fighting immune system cells called neutrophils.   Continued...

 

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