IL CHMP (EMEA) CONCEDE L’OPINIONE POSITIVA A MARAVIROC, NOME COMMERCIALE CELSENTRI, FARMACO DI UNA NUOVA CLASSE PER IL TRATTAMENTO DELL’HIV. PER LA PRIMA VOLTA IN EUROPA SARA’ IN COMMERCIO PROBABILMENTE PRIMA DEGLI USA. DA UTILIZZARSI IN PAZIENTI PRETRATTATI CON TROPISMO R5.
COMUNICATO DI PFIZER (AZIENDA PRODUTTRICE DEL FARMACO)
PFIZER RECEIVES POSITIVE OPINION FROM CHMP FOR CELSENTRI® (MARAVIROC) FOR TREATMENT-EXPERIENCED PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
NEW YORK, July 19 — Pfizer Inc announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending marketing authorization for Celsentri® (maraviroc), the first CCR5 antagonist for use in combination with other antiretroviral agents for treatment-experienced adult patients where only CCR5-tropic virus is detectable.
The CHMP’s positive opinion will be reviewed by the European Commission, which has authority to approve medicines for the European Union. Pfizer anticipates a final decision from the Commission in the coming months.
Maraviroc is the first member of a new class of oral HIV medicines in more than a decade (CCR5-antagonists). Discovered and developed by Pfizer scientists in Sandwich, England, since 1997, maraviroc works extracellularly by blocking viral entry to human cells. Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering white blood cells by blocking its predominant entry route, the CCR5 co-receptor.
In the treatment of HIV two parameters are considered main markers of treatment success: viral load reduction and increase of CD4 white cells. The maraviroc MOTIVATE pivotal trials compared the safety and efficacy of the addition of maraviroc to an optimized combination drug regimen (referred to as optimized background therapy-OBT) to the addition of placebo to OBT.
Twenty-four week data from the two maraviroc MOTIVATE trials presented at CROI (Conference on Retroviruses and Opportunistic Infections – February 2007) showed that:
Maraviroc and optimized background therapy provided substantially greater viral load reduction compared to patients receiving OBT alone. Nearly twice as many patients treated with maraviroc (two times per day) plus optimized background therapy (OBT) achieved undetectable viral loads (< 50 copies/ml HIV RNA) compared to those receiving placebo plus OBT (MOTIVATE-1, 48.5% versus 24.6%; MOTIVATE-2, 40.8% versus 20.9%). The group receiving maraviroc in the MOTIVATE trials demonstrated significantly greater increases in CD4 white cells compared to the group receiving OBT alone. The rate of most common adverse events (diarrhoea, nausea and headache) as well as rates of discontinuation due to adverse events were similar in patients receiving maraviroc and OBT compared with those receiving placebo and OBT. Forty-eight week data have further confirmed these findings and led to the positive opinion from the CHMP.