FDA Advisory Committee Recommends Approval of Pfizer's Selzentry

Pfizer Inc.Pfizer Inc. (NYSE: PFE) announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of Selzentry® (maraviroc) tablets for use in treatment-naïve adult patients with CCR5-tropic HIV-1 virus as part of combination therapy.

"Pfizer is pleased that the Committee has recognized the effectiveness and safety profile of maraviroc in patients who are starting HIV therapy," said Dr. Howard Mayer, Pfizer's executive director and disease area leader, antivirals. "Today's discussion marks an important step in expanding available treatment options for patients with HIV infection and we look forward to working with the FDA to further address the points raised by the panel."

Selzentry was granted accelerated approval in August 2007 and full approval in November 2008 by the FDA for use in treatment-experienced adult patients with only CCR5-tropic HIV-1 virus in combination with other antiretroviral therapies. Selzentry is an oral medicine that blocks viral entry to human cells. Rather than fighting HIV inside white blood cells, Selzentry prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

In making its decision, the Advisory Committee reviewed 48- and 96-week efficacy and safety data from the ongoing Phase 3 MERIT (Maraviroc versus Efavirenz Regimens as Initial Therapy) trial and MERIT ES (analysis of the MERIT study with the enhanced sensitivity Trofile™ assay).

Results of MERIT at 48-weeks showed that Selzentry plus Combivir® (zidovudine/lamivudine) was as effective as Sustiva® (efavirenz) plus zidovudine/lamivudine at reducing viral load for the co-primary endpoint of <400 copies/mL, but did not show non-inferiority for the co-primary endpoint of <50 copies/mL at 48-weeks. Safety results at 96-weeks showed that among those patients who remained on therapy, less than half the number of malignancies were observed in patients taking Selzentry compared to those taking efavirenz. Additionally, no new safety signals were identified in association with Selzentry at 96-weeks. The most frequently reported adverse events were nausea, headache, dizziness, diarrhea, fatigue, upper respiratory tract infection, and vomiting. Patients were screened into the study using the original Trofile™ assay which is no longer available.

MERIT ES is a retrospective analysis, which utilized the enhanced sensitivity Trofile™ assay in screening samples from the MERIT trial. Results of MERIT ES at 48-weeks showed that treatment-naïve patients with CCR5-tropic HIV-1 taking Selzentry plus zidovudine/lamivudine experienced comparable virologic suppression to undetectable levels (<50 copies/mL) to those taking efavirenz plus zidovudine/lamivudine. The enhanced sensitivity Trofile™ assay used in the MERIT ES analysis has been the only available version of the Trofile™ assay since June 2008.

The FDA often seeks the advice of its Advisory Committees when evaluating potential treatments, but is not required to follow its recommendation. Through the joint venture with GlaxoSmithKline, which is expected to close in the fourth quarter of 2009, Pfizer remains committed to the expansion of Selzentry/Celsentri's current indications to include appropriate treatment-naïve populations throughout the world.

At the end of 2006, an estimated 1.1 million people in the U.S. were living with HIV infection. The Centers for Disease Control and Prevention (CDC) estimates that in 2006 approximately 56,300 people were newly infected with HIV in the U.S. (the most recent year that data are available).

About Selzentry
Selzentry has been approved for use in treatment-experienced adult patients with only CCR5-tropic HIV-1 virus detectable in combination with other antiretroviral therapies, in several other markets around the world including the U.S., Canada and the European Union.

Maraviroc is marketed under the trade name Selzentry® in the U.S. and Celsentri® in all other countries in which it is approved.

Pfizer Inc: Working together for a healthier world™
Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Most Popular Now

Pfizer begins a Phase 1/2 study to evaluate respir…

Pfizer Inc. (NYSE:PFE) today announced that it has started a Phase 1/2 trial of its respiratory syncytial virus (RSV) vaccine candidate in healthy adult volunteers. RSV i...

Eczema drug effective against severe asthma

Two new studies of patients with difficult-to-control asthma show that the eczema drug dupilumab alleviates asthma symptoms and improves patients' ability to breathe bett...

Most popular vitamin and mineral supplements provi…

The most commonly consumed vitamin and mineral supplements provide no consistent health benefit or harm, suggests a new study led by researchers at St. Michael's Hospital...

AstraZeneca heads to 2018 ASCO Annual Meeting with…

AstraZeneca and MedImmune, its global biologics research and development arm, head to the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, US...

Tiny particles could help fight brain cancer

Glioblastoma multiforme, a type of brain tumor, is one of the most difficult-to-treat cancers. Only a handful of drugs are approved to treat glioblastoma, and the median ...

Novartis data at ASCO and EHA reinforce company's …

Novartis will present data from across its oncology portfolio at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) to be held June 1-5 ...

Spiolto® Respimat® enables greater physical activi…

Boehringer Ingelheim announced data which add to the growing body of evidence that show Spiolto® (tiotropium/olodaterol) Respimat® enables greater physical activity in pa...

New approach to immunotherapy leads to complete re…

A novel approach to immunotherapy developed by researchers at the National Cancer Institute (NCI) has led to the complete regression of breast cancer in a patient who was...

Amgen Foundation and Harvard team up to offer free…

The Amgen Foundation and Harvard University today announced plans to launch a free online science education platform uniquely designed to level the playing field for aspi...

Study demonstrates new treatment for severe asthma

Researchers from McMaster University and the Firestone Institute for Respiratory Health at St. Joseph's Healthcare Hamilton, together with colleagues at other partnering ...

The Pfizer Foundation announces $5 million in gran…

The Pfizer Foundation announced a new $5 million grant commitment to initiatives in low- and middle-income countries that provide family planning access and education for...

Study finds antioxidant-enriched vitamin reduces r…

Researchers at Children's Hospital Colorado (Children's Colorado) and the University of Colorado School of Medicine have found that taking a specially formulated antioxid...