Pfizer's Selzentry granted full US approval

The US Food and Drug Administration has granted world drug giant Pfizer's Selzentry (maraviroc) full approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals.

Full approval removes restrictions on promotion and distribution that apply to conditionally-cleared medicines. The viral entry blocker was originally granted accelerated conditional approval in August 2007 based on 24-week data from Phase III studies and was given the nod by an FDA panel a few months before (Marketletter April 30, 2007).

Pfizer says that the FDA's Antiviral Drugs Advisory Committee voted unanimously to recommend the approval of its CCR5 antagonist maraviroc for use along with other antiretrovirals for treatment-experienced patients infected with CCR5-tropic HIV-1.