Pfizer to Withdraw Global Marketing Applications for Dalbavancin
Pfizer has announced it will globally withdraw all dalbavancin marketing applications for the treatment of complicated skin and skin structure infections in adults, including the US new drug application and the European marketing authorization application.
Following feedback from regulatory authorities, the company plans to conduct an additional Phase III clinical 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).
The global multi-center study will generate additional clinical data to support planned future regulatory submissions. A pediatric program with dalbavancin is also planned.
Dalbavancin, a member of the glycopeptide class of antibiotics, was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals.
Mark Kunkel, Pfizer’s global medical therapeutic area leader for anti-infectives and HIV, said: “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.
“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.”