Allergan announced that the Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) for Dalvance (dalbavancin) to expand its label to include single-dose administration 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 1500mg dose of Dalvance with the current two-dose regimen of 1000mg followed by 500mg one week later. Data demonstrated the 1500mg single dose 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, the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen, is a second generation, semi-synthetic lipoglycopeptide.
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