Pfizer's
Selzentry (Maraviroc) Tablets, Novel Treatment for HIV, Approved by FDA NEW
YORK--(BUSINESS WIRE)--Aug 6, 2007 - Pfizer Inc announced today that the U.S.
Food and Drug Administration (FDA) has approved SelzentryTM (maraviroc) tablets,
the first in a new class of oral HIV medicines in more than 10 years. Selzentry
blocks viral entry into white blood cells, significantly reducing viral load and
increasing T-cell counts in treatment-experienced patients infected with a specific
type of HIV.
"There is a profound need for new medicines to treat
HIV. In the United States, thousands of patients living with HIV are running out
of effective medications that can control their virus," said Dr. Joseph Feczko,
Pfizer's chief medical officer. "The approval of Selzentry for treatment-experienced
patients is a significant breakthrough, and we continue its development in a spectrum
of other patients living with HIV/AIDS." The
FDA granted accelerated approval to Selzentry for combination antiretroviral treatment
of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of
viral replication and have HIV-1 strains resistant to multiple antiretroviral
agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic
HIV-1, which is also known as "R5 virus." An
accelerated approval allows for earlier approval of drugs that provide a meaningful
therapeutic advantage over existing treatment for serious or life-threatening
diseases. This approval is based on 24-week data. Longer-term data will be required
before the FDA can consider traditional approval for Selzentry. Selzentry
is the first in a class of drugs known as CCR5 antagonists, which block the CCR5
co-receptor, the virus' predominant entry route into T-cells. Selzentry stops
the R5 virus on the outside surface of the cells before it enters, rather than
fighting the virus inside as do all other classes of oral HIV medicines. Selzentry
is expected to be available in the U.S. by the middle of September. Pfizer
is currently submitting marketing applications around the world and recently received
a positive opinion from the CHMP in the EU. Pfizer intends to commercialize the
product with the name Celsentri outside of the U.S. Pfizer
has established a multi-national expanded access program (EAP), a clinical study
that provides Selzentry in countries where it is not yet commercially available
to patients who have limited treatment options due to resistance or intolerance
to existing therapies. Pfizer's
Ongoing Commitment to HIV/AIDS Pfizer
scientists discovered Selzentry in 1997. Selzentry'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.
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 Pfizer's products,
partnerships, pipeline and philanthropy. Current
initiatives include the Southern HIV/AIDS Prevention Initiative, the building
of the Infectious Disease Institute in Kampala, Uganda, the Pfizer Global Health
Fellows Program and the Diflucan Partnership Program. Most
recently in April 2007, Pfizer launched ConnectHIV, a three year initiative that
will provide $7.5 million in grants and capacity building to twenty community-based
AIDS Service Organizations in communities of greatest need in the U.S. ConnectHIV
grantee organizations were chosen based on a demonstrated commitment to comprehensive
approaches to improving HIV prevention efforts in underserved populations. Data
Supporting Selzentry Approval The
FDA approval of Selzentry is based on 24-week data from the ongoing double-blind,
controlled MOTIVATE clinical trials. In the MOTIVATE trials, approximately twice
as many patients receiving Selzentry combined with an optimized background therapy
(OBT) achieved undetectable viral load at 24 weeks compared with those receiving
OBT alone. In
the trials, patients receiving Selzentry with OBT also experienced significantly
greater viral load reductions and increases in CD4 cell counts compared with those
receiving OBT alone. Patients
in the MOTIVATE trials were highly treatment-experienced, with 69.7% receiving
Selzentry and OBT and 66% receiving OBT alone having two or fewer active drugs
in their optimized background regimen. Patients
receiving Selzentry in the studies had a rate of discontinuation due to adverse
events (3.8%) which was similar to the group receiving OBT plus placebo (3.8%).
The most common adverse reactions (greater than8% incidence and greater than placebo)
are cough, pyrexia (fever), upper respiratory tract infections, rash, musculoskeletal
symptoms, abdominal pain, and dizziness. Important
Safety Information Selzentry
does not cure HIV infection or AIDS, and does not prevent passing HIV to others.
Although there
was no overall increase in serious liver function test abnormalities in patients
treated with Selzentry, hepatotoxicity has been reported with Selzentry use. Evidence
of a systemic allergic reaction (e.g., pruritic rash, eosinophilia or elevated
IgE) prior to the development of hepatotoxicity may occur. Patients with signs
or symptoms of hepatitis or allergic reaction following use of Selzentry should
be evaluated immediately. The
safety and efficacy of Selzentry have not been specifically studied in patients
with significant underlying liver disorders. However, caution should be used when
administering Selzentry to patients with pre-existing liver dysfunction or who
are co-infected with viral hepatitis B or C. In
clinical studies, more cardiovascular events, including myocardial ischemia and/or
infarction, were observed in patients who received Selzentry as compared to placebo.
Selzentry should be used with caution in patients at increased risk for cardiovascular
events. Caution
should be used when administering Selzentry in patients with a history of postural
hypotension or who receive concomitant medication known to lower blood pressure.
Patients should be advised that if they experience dizziness while receiving Selzentry,
they should avoid driving or operating machinery. Immune
reconstitution syndrome has been reported in patients treated with combination
antiretroviral therapy. Selzentry
antagonizes the CCR5 co-receptor located on some immune cells, and therefore could
potentially increase the risk of developing infections and malignancy. For
full prescribing information for Selzentry, including boxed warning, or for more
information on these and other Pfizer initiatives, go to www.pfizer.com.
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request free broadcast-standard video about this announcement digitally or by
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Contact Pfizer
Inc
Shreya Prudlo, 212-733-4889 | 
