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[ by Nora Proops | Oct 10, 2009 10:49 am | 3 Comments ]
FDA Committee Supports Selzentry For Use In Treatment-Naïve Patients

On October 8, the Antiviral Drugs Advisory Committee of the Food and Drug Administration (FDA) recommended approval of Selzentry (maraviroc) for use in treatment-naïve patients. The Committee voted 10-4 in favor of extending Selzentry’s use to newly diagnosed individuals, but the FDA has yet to grant official approval.

Selzentry was originally approved for treatment-experienced patients in 2007. Pfizer, Selzentry’s manufacturer, applied for its expanded use in September after receiving results from study 1026.

Study 1026 compared a 300 mg dose of Selzentry given twice daily in combination with Combivir (zidovudine/lamivudine)…

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