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Pfizer’s Selzentry Gains Full Approval

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By: Tim Wright

Editor-in-Chief, Contract Pharma

The FDA has granted Pfizer’s Selzentry (maraviroc) full approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. Selzentry was originally granted accelerated conditional approval in August 2007 based on 24-week data from Phase III studies.  
   
The full approval 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 therapeutic advantage over existing treatments for serious or life-threatening diseases. The FDA grants full approval status once longer-term safety and efficacy data is established. Once full approval is granted, restrictions that apply to conditionally approved medicines are lifted.
   
“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.”

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