FDA Accepts sNDA for Dalvance

10/08/2015

The FDA accepted Allergan's supplemental New Drug Application (sNDA) to expand the label to include single-dose administration of DALVANCE® (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The application was based on results from a Phase 3 study DUR001-303, which compared a single 1500 mg dose of DALVANCE with the two-dose regimen of 1000 mg followed one week later by 500 mg.  Data demonstrated the 1500 mg single dose of DALVANCE achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48 to72 hours after initiation of therapy, as determined by a decrease of > 20% in lesion area relative to the baseline measurement (81.4% vs. 84.2% for the single dose vs. the two dose regimen, respectively; Difference -2.9; 95% CI: -8.5, 2.8).

DALVANCE was first approved in the US in May 2014 for the treatment of ABSSSI in adults. DALVANCE is the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg.

DALVANCE is marketed in the European Union as XYDALBA™ (dalbavancin) for injection for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.

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