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

How SARS-CoV-2 mutates to escape antibody binding

In a recurring pattern of evolution, SARS-CoV-2 evades immune responses by selectively deleting small bits of its genetic sequence, according to new research from the Uni...

Anticancer drug may improve outcome for severe COV…

Treating severe COVID-19 patients with the anticancer drug bevacizumab may reduce mortality and speed up recovery, according to a small clinical study in Italy and China ...

One dose of COVID-19 vaccine provokes strong immun…

Although clinical trial data are encouraging, real-world evidence with regard to the COVID-19 vaccine remains scarce. In particular, response to the vaccine among those p...

Pfizer and BioNTech commence global clinical trial…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) announced today that the first participants have been dosed in a global Phase 2/3 study to further evaluate the saf...

Johnson & Johnson announces submission of appl…

Johnson & Johnson (NYSE: JNJ) (the Company) announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting E...

Could a nasal spray prevent coronavirus transmissi…

A nasal antiviral created by researchers at Columbia University Vagelos College of Physicians and Surgeons blocked transmission of SARS-CoV-2 in ferrets, suggesting the n...

European Commission purchases additional 150 milli…

Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today announced that the European Commission purchased an...

GSK and Vir Biotechnology expand coronavirus colla…

GlaxoSmithKline plc (LSE/NYSE: GSK) and Vir Biotechnology, Inc. (Nasdaq: VIR) have signed a binding agreement to expand their existing collaboration to include the resear...

Neandertal gene variants both increase and decreas…

Last year, researchers at Karolinska Institutet in Sweden and the Max Planck Institute for Evolutionary Anthropology in Leipzig, Germany showed that a major genetic risk ...

CureVac initiates rolling submission with European…

CureVac N.V. (Nasdaq: CVAC), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (mRNA), today annou...

Pfizer and BioNTech publish data from in vitro stu…

Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the publication in Nature Medicine of data from in vitro studies that demonstrate that sera from in...

Sinovac receives conditional marketing authorizati…

Sinovac Biotech Ltd. (NASDAQ:SVA) ("Sinovac" or the "Company"), a leading provider of biopharmaceutical products in China, announced that the China National Medical Produ...