Pfizer's Celsentri gets CHMP nod

US drug giant Pfizer says that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Celsentri (maraviroc) in HIV infection. Specifically, the CHMP advised that the drug be cleared, in combination with antiviral agents, in adult treatment-experienced patients in whom the virus has become resistant.

The agent, which is a CCR5-antagonist, prevents viral entry into immune cells blocking interaction with the CCR5 co-receptor. In trials, presented at this year's Conference on Retroviruses and opportunistic Infections in Boston, USA, the drug was shown to confer greater viral load reductions when combined with optimized background therapy than OBT alone. In addition, nearly double the number of patients who received the treatment achieved undetectable viral loads than those on OBT (48.5% versus 24.6%).

Pfizer, which recently received a US Food and Drug Administration "approvable letter" for the drug (Marketletter June 25), said that it expects a final EMEA clearance decision in the next few months.