FDA accepts filing of sNDA to provide for single dose Dalvance (dalbavancin) for ABSSSI (skin infections)- Allergan

Allergan has announced that the FDA has accepted for filing 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 III study DUR001-303, which compared a single 1500 mg dose of dalbavancin with the two-dose regimen of 1000 mg followed one week later by 500 mg. Data demonstrated the 1500 mg single dose of dalbavancin achieved its primary endpoint of non-inferiority to the two-dose regimen (10% non-inferiority margin) at 48 to 72 hours after initiation of therapy. Dalbavancin was first approved in the US in May 2014 for the treatment of ABSSSI in adults. Dalbavancin 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.

Comment: 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.