First in a New Oral Class of HIV Medicines in 10 Years
Pfizer Inc announced today that the European Commission (EC) has
approved Celsentri(R) (maraviroc). Treatment-experienced HIV patients
in the EU can soon benefit from the first CCR5 antagonist and only
oral entry inhibitor. Maraviroc, in combination with other
antiretroviral medicinal products, is indicated for
treatment-experienced adult patients infected with only CCR5-tropic
HIV-1 virus detectable.
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, UK, since 1997, maraviroc works by
blocking viral entry into 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.
"HIV is a significant health concern in Europe and infection rates
are still increasing. Without new medicines, resistance to current
treatments is one of the biggest challenges facing HIV care today,"
said Filippo von Schloesser, president of Italian HIV patient
organization, Fondazione Nadir Onlus. "The approval of maraviroc will
offer a new option to many people living with HIV in Europe."
The EC approval of maraviroc is based on 48-week data from the two
ongoing double-blind, placebo-controlled MOTIVATE clinical trials. The
data of the MOTIVATE trials show that:
-- Maraviroc and optimized background therapy (OBT) provided
substantially greater viral load reduction compared to
patients receiving OBT alone.
-- More than twice as many patients receiving maraviroc plus
optimized background therapy (OBT) achieved undetectable viral
load at 48 weeks compared with those receiving OBT alone.
-- The group receiving maraviroc and OBT in the MOTIVATE trials
demonstrated significantly greater increases in CD4 white
cells compared to the group receiving OBT alone.
-- The rates of most frequently reported adverse reactions
(diarrhoea, nausea and headache) were similar in patients
receiving maraviroc and OBT compared with those receiving OBT
alone.
-- Patients treated with maraviroc and OBT had low
discontinuation rates (3.8%) similar to the group receiving
OBT alone (3.8%).
"Maraviroc is an important additional treatment option for R5
tropic treatment-experienced patients in Europe," noted Gerd
Faetkenheuer, MD, Department of Internal Medicine, University of
Cologne, Germany. "Although other treatments are currently available,
maraviroc targets the fight against the HIV virus in a new way."
Further details and product information will be available in the
European Public Assessment Report on the web site of the European
Medicines Agency at www.emea.europa.eu.
Pfizer's Ongoing Commitment to HIV/AIDS
Pfizer scientists discovered maraviroc in 1997. Maraviroc's
clinical program initiated the first combined phase 2b/3 trial design
in HIV to efficiently characterize its clinical profile and submit
data to regulatory authorities as quickly as possible. Maraviroc,
known as Selzentry(TM) in the United States, was approved by the U.S.
Food and Drug Administration (FDA) on August 6, 2007 and is currently
available in the U.S.
In December 2006, Pfizer announced plans to establish a
multi-national Expanded Access Program, a clinical study that provides
maraviroc to patients who have limited or no approved treatment
options due to resistance or intolerance to existing drug classes. The
program is open for enrollment with a target to enroll patients from
over 30 countries.
Pfizer is committed to bringing meaningful improvement to the
lives of people living with HIV/AIDS and those at risk around the
world. This commitment is embodied in significant philanthropic
activities that provide access to life-saving medicines, resources and
skills to help improve patient care for people throughout the world
living with HIV/AIDS.
Current initiatives include the building of the Infectious Disease
Institute in Kampala, Uganda, the Pfizer Global Health Fellows
Program, the Diflucan Partnership Program and ConnectHIV, an HIV
prevention program in the U.S.