Single-Dose Antibiotic for ABSSSI, Including MRSA, Accepted for Review

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).

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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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