Pfizer will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the U.S. NDA and the European MAA.
Following feedback from regulatory authorities, the company plans to conduct an additional Phase III trial with dalbavancin for the treatment of adults with complicated skin and skin structure infections caused by Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus), a virulent and potentially deadly bacterium. The global study will generate additional data to support planned future regulatory submissions. A pediatric program with the drug is also planned.
“After careful consideration of feedback and ongoing dialogue with regulatory authorities, Pfizer has decided to study dalbavancin further in patients with complicated skin and skin structure infections,” said Dr. Mark Kunkel, Pfizer’s global medical therapeutic area leader for anti-infectives and HIV. “Dalbavancin represents a potential important treatment advance and Pfizer is committed to ongoing research of its use in patients who suffer from serious skin infections, including those caused by MRSA.”
Pfizer acquired the drug in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.