New Antibiotic Approved for Skin Infections, Including MRSA

The FDA has approved Dalvance (dalbavancin; Durata Therapeutics) for injection for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including MRSA (methicillin resistant Staphylococcus aureus). Dalvance is the first intravenous antibiotic approved for the treatment of ABSSI with a 2-dose regimen.

Dalvance’s safety and efficacy were evaluated in 2 clinical studies (DISCOVER 1 and DISCOVER 2) involving 1,289 adults with ABSSSI. Patients were randomized to receive Dalvance or vancomycin. Results showed Dalvance was non-inferior to the comparator regimen and met its primary and secondary endpoints of early response, measured at 48–72 hours of therapy, as well as clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever.

RELATED: QIDP Designation for Dalbavancin for Acute Bacterial Skin and Skin Structure Infections

Dalbavancin, a 2nd generation semisynthetic lipoglycopeptide, interferes with cell wall synthesis by binding to the D-alanyl-D-alanine terminus of the stem pentapeptide in nascent cell wall peptidoglycan, thus preventing cross-linking.

Dalvance for injection will be available in 500mg single-use vials.

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