HIV Drug Passes FDA Advisory Panel Hurdle – Prevents HIV From Entering Cells - New Class of Drugs – Undetectable Viral Loads

HIV Drug Passes FDA Advisory Panel Hurdle – Prevents HIV From Entering Cells - New Class of Drugs – Undetectable Viral Loads

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(Best Syndication) A Food and Drug Administration (FDA) advisory panel recommended approval of Pfizer’s Maraviroc drug for use in treating HIV Tuesday. Although the FDA has no obligation to approve the recommendations of their advisory panels, they usually do.

Maraviroc blocks HIV from entering white blood cells through a pathway present in some patients. Pfizer says this is the first in a new class of oral HIV medicines in more than a decade. The vote was unanimous (12-0) in favor of approval for the antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1.

Unlike other drugs, Maraviroc tries to fight the disease by blocking viral entry to human cells, rather than fighting HIV inside white blood cells. The drug prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

Recent research has shown that Maraviroc in combination with optimized background therapy (OBT) achieved undetectable viral loads at 24 weeks compared to those receiving placebo plus OBT.

According to a statement from Pfizer, there were no significant increases in hepatotoxicity, malignancy or mortality in maraviroc’s treatment arms, but there were slight increases in upper respiratory and herpes simplex virus infections. There were also increases in ischemic events, consistent with the rate observed in treatment experienced HIV/AIDs patients.

Maraviroc is currently undergoing expedited regulatory review.

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By Marsha Quinn
Best Syndication Health Writer



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