FDA approves epipen rival

The FDA has approved a supplemental new drug application (sNDA) to update the label for dalbavancin (Dalvance, Allergan) for injection. The expanded label will include a single dose administered as a 30-minute intravenous infusion of dalbavancin for the treatment of acute bacterial skin and skin-structure infections (ABSSSIs) caused by designated susceptible gram-positive bacteria in adults, including infections caused by methicillin-resistant Staphylococcus aureus (MRSA).

The sNDA was based on results from a phase 3 study that compared a single 1,500-mg dose of dalbavancin with the two-dose regimen of 1,000 mg followed one week later by 500 mg. The 1,500-mg single dose of dalbavancin achieved its primary endpoint of noninferiority to the two-dose regimen (10% noninferiority margin) at 48 to 72 hours after the initiation of therapy, as determined by a decrease of 20% or more in lesion area compared with the baseline measurement (81.4% vs. 84.2% for the single-dose vs. the two-dose regimen, respectively).

Dalbavancin is now the only 30-minute, single-dose treatment option for ABSSSIs that delivers a full course of IV therapy, providing an alternative dosing option for physicians, according to Allergan. The product was first approved in the U.S. in May 2014 for the treatment of ABSSSIs in adults.

Dalbavancin is a second-generation, semisynthetic lipoglycopeptide that consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. The compound has demonstrated bactericidal activity in vitro against a range of gram-positive bacteria, such as S. aureus (including MRSA strains) and Streptococcus pyogenes, as well as certain other streptococcal species.

Source: Allergan; January 21, 2016.

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