Pfizer gets US FDA approvable letter for Dalbavancin

The pharma major Pfizer has received an approvable letter from US Food and Drug Administration (FDA) for Dalbavancin HCl. This drug is Pfizer's once-weekly two-dose antibiotic under FDA review for the treatment of adult patients with complicated skin and skin structure infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).

The US regulator recently published a draft guidance on studies designed to show non-inferiority as a basis for approving antibacterial drug products and requested Pfizer to provide additional data with regard to Dalbavancin. Pfizer is working with the FDA to respond to these new requirements.

Also, the FDA approvable letter refers to deviations from current good manufacturing practices (cGMP) at a third party manufacturer, not specifically related to Dalbavancin. The third-party manufacturer is working with the FDA to resolve outstanding manufacturing issues. Pfizer is also addressing a question from the FDA regarding length of storage time following reconstitution of Dalbavancin.

Dalbavancin, a member of the Glycopeptide class of antibiotics, represents an important addition to Pfizer's broad portfolio of antibacterial products and product candidates. Dalbavancin was acquired by Pfizer in September 2005 as part of its acquisition of Vicuron Pharmaceuticals, Inc.

The company has a long history of developing new medicines for treating infectious diseases and remains committed to providing physicians with this important new treatment option for skin infections caused by MRSA.

MRSA is a virulent and potentially deadly bacterium, and MRSA infections are on the rise in hospitals, long-term care facilities and within communities. MRSA is resistant to many classes of commonly used antibiotics and can cause several types of infections, with skin infections being the most common. The Infectious Diseases Society of America (IDSA) has included MRSA on a reported Hit List of top-priority, dangerous drug resistant microbes that require additional research and new treatments.