Allergan Says FDA Accepts Supplemental New Drug Application For DALVANCE

(RTTNews) - Allergan plc, (AGN) announced that the U.S. Food and Drug Administration or FDA has accepted for filing its supplemental New Drug Application or sNDA for DALVANCE.

The company said this filing will expand the label to include single-dose administration of DALVANCE for the treatment of acute bacterial skin and skin structure infections or ABSSSI in adults caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus or 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 at 48 to72 hours after initiation of therapy, as determined by a decrease of 20% in lesion area relative to the baseline measurement.

DALVANCE was first approved in the U.S. 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.