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Title: FDA Grants Full Approval of Maraviroc for Treatment-Experienced Patients With HIV

"FDA Grants Full Approval of Maraviroc for Treatment-Experienced Patients With HIV"

NEW YORK -- November 26, 2008 -- The US Food and Drug Administration (FDA) has granted full approval of maraviroc (Selzentry) for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. "New, effective, and well-tolerated treatment options are critical for treatment-experienced persons living with HIV infection," said W. David Hardy, MD, Division of Infectious Diseases, Cedars-Sinai Medical Center and the David Geffen School of Medicine, University of California, Los Angeles, Los Angeles, California. "[Maraviroc], the first oral entry inhibitor, has proven to be an effective and well-tolerated treatment option for treatment-experienced patients whose HIV has become resistant to other treatments, but remains susceptible to this new class of medications." The full approval of maraviroc is based on 48-week data from the Maraviroc Plus Optimized Therapy in Viremic Antiretroviral Treatment Experienced Patients (MOTIVATE) studies. The studies compared the safety and effectiveness of maraviroc plus optimised background therapy with placebo plus optimised background therapy in treatment-experienced CCR5-tropic HIV-1 patients. Results of the 48-week data showed that a greater log reduction in viral load from baseline was seen in patients receiving maraviroc plus optimised background therapy, compared with those patients receiving placebo plus optimised background therapy. More than twice as many patients receiving maraviroc plus optimised background therapy over 48-weeks achieved undetectable viral loads (<50 copies/mL HIV RNA) compared with those receiving placebo plus optimised background therapy in treatment-experienced CCR5-tropic HIV-1-infected patients. In additions, patients treated with maraviroc plus optimised background therapy achieved a significantly higher increase in CD4 cells than those receiving placebo plus optimised background therapy. Data showed no clinically relevant differences in the safety profile between the study treatment groups and remained consistent with 24-week results. The most common adverse events included upper respiratory tract infections, cough, pyrexia, rash, and dizziness. SOURCE: Pfizer

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