FDA Approves Allergan New Dosing for Dalvance

FDA has approved an Allergan supplemental NDA to update the label for Dalvance (dalbavancin) for injection to include a single dose administered as a 30-minute intravenous (IV) infusion for treating acute bacterial skin and skin structure infections (ABSSSI) caused by designated susceptible Gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus. The company says that Dalvance is the “first and only 30-minute, single-dose treatment option for ABSSSI that delivers a full course of IV therapy, providing an alternative dosing option for physicians.”

 

The submission was based on results from a Phase 3 study, DUR001-303, which compared a single 1,500 mg dose of Dalvance with the two-dose regimen of 1,000 mg followed one week later by 500 mg. Data demonstrated the 1,500 mg single dose achieved its primary endpoint of non-inferiority to the two-dose regimen, the company says.