Pfizer puts brakes on dalbavancin15th September 2008
Pfizer has announced it will withdraw global marketing applications for its dermatological antibiotic dalbavancin pending new clinical trials.
The company said the drug, which was developed for the treatment of complicated skin and skin structure infections in adults, would need to undergo additional Phase 3 trials.
The trials would look at its safety and effectiveness in the treatment of adults with complicated skin and skin structure infections caused by Gram-positive bacteria, including MRSA (methicillin resistant staphylococcus aureus).
Until the trials were complete, global applications, including the US new drug application (NDA) and the European marketing authorisation application (MAA), would be withdrawn.
The decision follows feedback from regulatory authorities, the company said.
The new trial will take place at multiple centres around the world, and is expected to generate additional clinical data to support planned future regulatory submissions.
The company is also planning a separate, paediatric programme with dalbavancin.
Mark Kunkel, Pfizer's Global Medical Therapeutic Area Leader for Anti-infectives and HIV, said an ongoing dialogue with drug regulators had prompted the company to study dalbavancin further in patients with complicated skin and skin structure infections.
Kunkel said Pfizer was committed to ongoing research into such infections, including those caused by MRSA.
Dalbavancin is part of the glycopeptide class of antibiotics. It was acquired by Pfizer in 2005 when the company took over Vicuron Pharmaceuticals.
MRSA is behind many potentially deadly hospital-acquired infections, but is also found in long-term care facilities and in communities.
Resistant to many classes of commonly used antibiotics, it can cause several types of infections, with skin infections being the most common.
MRSA has been added to a 'hit list' of microbes in need of new research and treatments by the Infectious Diseases Society of America.
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