United States : FDA Advisory Committee approves Selzentry tablets for use in patients starting HIV therapy.Pfizer Inc. (NYSE NYSE See: New York Stock Exchange : PFE 1. (text, editor) PFE - Programmer's File Editor. 2. (language) PFE - Portable Forth Environment. ) announced today that the U.S. Food and Drug Administration s (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) Antiviral Drugs Advisory Committee voted (10 to 4) to recommend the approval of SelzentryA; (maraviroc) tablets for use in treatment-naive 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 HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. 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 White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies , 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 efavirenz /ef·a·vi·renz/ (ef´ah-vi?renz) an antiretroviral, inhibiting reverse transcriptase; used in the treatment of HIV infection. e·fa·vir·enz n. 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 CombivirA; (zidovudine/lamivudine) was as effective as SustivaA; (efavirenz) plus zidovudine/lamivudine at reducing viral load for the co-primary endpoint of Copyright : Euclid Infotech Pvt. Ltd. Provided by Syndigate.info an Albawaba.com company |
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