SELZENTRY was originally granted accelerated conditional approval in August 2007 based on 24-week data from pivotal Phase 3 studies. SELZENTRY now becomes the latest fully approved treatment for HIV.
“New, effective and well-tolerated treatment options are critical for treatment-experienced persons living with HIV infection,” said W. David Hardy, MD, chief of the Division of Infectious Diseases, Cedars-Sinai Medical Center and Associate Professor of Medicine at the David Geffen School of Medicine, University of California, Los Angeles (UCLA). “Selzentry, 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 SELZENTRY is based on 48-week data from the MOTIVATE (Maraviroc Plus Optimized Therapy in Viremic Antiretrovial Treatment Experienced Patients) studies. The studies compared the safety and effectiveness of SELZENTRY plus optimized background therapy to placebo plus optimized background therapy in treatment-experienced CCR5-tropic HIV-1 patients.
Accelerated conditional approval is granted to medicines that provide a meaningful therapeutic advantage over existing treatments for serious or life-threatening diseases. FDA grants full approval status once it is satisfied with longer-term safety and efficacy data. Once full approval is granted, restrictions on promotion and/or distribution that apply to conditionally approved medicines are removed.
“SELZENTRY has been on a long journey, from its initial discovery by Pfizer scientists in 2000 to this full FDA approval,” said Dr. Howard Mayer, Pfizer's executive director, and development team leader for HIV/AIDS. “We are extremely excited with this important milestone in SELZENTRY's lifecycle and the potential improvement it may bring to treatment-experienced people living with HIV/AIDS.”
Results at Week 48 from the MOTIVATE studies were recently published in the October 2, 2008 edition of the New England Journal of Medicine.
For more information on the approved U.S. label, including a boxed warning, please see full prescribing information available at www.SELZENTRY.com.
