Pfizer (PFE) Receives FDA Approval for Selzentry

August 6, 2007 1:07 PM EDT

Pfizer Inc (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved SelzentryTM (maraviroc) tablets, the first in a new class of oral HIV medicines in more than 10 years. Selzentry blocks viral entry into white blood cells, significantly reducing viral load and increasing T-cell counts in treatment-experienced patients infected with a specific type of HIV.

The FDA granted accelerated approval to Selzentry for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic HIV-1, which is also known as "R5 virus."

The FDA approval of Selzentry is based on 24-week data from the ongoing double-blind, controlled MOTIVATE clinical trials. In the MOTIVATE trials, approximately twice as many patients receiving Selzentry combined with an optimized background therapy (OBT) achieved undetectable viral load at 24 weeks compared with those receiving OBT alone.

Related Categories

FDA

Stocks Mentioned

Add Your Comment

Name

Subject

Body

Verification can't see the text?
click here to refresh the image.
what's this?