UPDATE 1-EU backs Pfizer HIV drug facing U.S. delay
(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) 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.
Invasive candidiasis is an infection that occurs when the Candida species of fungus enters the bloodstream, where it can then spread througout the body. People at greatest risk of the fungal condition are low-birthweight babies, surgery patients and those with immune deficiencies.
Recommendations for marketing approval by the Committee for Medicinal Products are normally endorsed by the European Commission within a few months.
(Reporting by Ransdell Pierson in New York, Jonathan Cable in London)
((Editing by Leslie Gevirtz; Reuters messaging: rm://jonathan.cable.reuters.com@reuters.net; +44 20 7542 4688; Email jonathan.cable@reuters.com)) Keywords: PFIZER ECALTA CELSENTRI/
(C) Reuters 2007. All rights reserved. Republication or redistribution ofReuters content, including by caching, framing or similar means, is expresslyprohibited without the prior written consent of Reuters. Reuters and the Reuterssphere logo are registered trademarks and trademarks of the Reuters group ofcompanies around the world.nN19435690
© Thomson Reuters 2009 All rights reserved

