Pfizer HIV drug gains positive CHMP opinion

Pfizer has announced that Celsentri (maraviroc), its therapy for treatment-experienced adult patients exhibiting CCR5-tropic HIV-1, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.

This opinion follows the presentation of 24-week data from two Motivate trials presented at the Conference on Retroviruses and Opportunistic Infections last February.

In these trials, patients receiving maraviroc in conjunction with optimised background therapy (OBT) showed a greater reduction in viral load compared to those solely administered with OBT.

Furthermore, nearly twice as many patients treated twice daily with maraviroc plus OBT exhibited undetectable viral loads compared to those administered with OBT and placebo.

Dr Joseph Feczko, chief medical officer of Pfizer, said: “New, effective and well-tolerated treatments are urgently needed for the thousands of people living with HIV whose virus has become resistant to one or more currently available options.”

He added that Pfizer had recognised these needs and consequently progressed in the development of maraviroc with a sense of urgency.

In March 2007, Pfizer noted that by blocking viral entry to human cells, the novel mechanism of maraviroc makes the compound potentially the first innovative orally-administered treatment for HIV developed in more than a decade.