FDA Accepts Allergan’s Supplemental New Drug Application (sNDA) for DALVANCE

Allergan plc has announced that the U.S. Food and Drug Administration (FDA) has accepted for filing Allergan’s supplemental New Drug Application (sNDA), for MRSA.

According to Allergan, this filing will 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).

“With the FDA’s acceptance of this supplemental application, Allergan is one step closer to providing a single-dose option of DALVANCE which may provide more flexibility to manage serious skin infections in an outpatient setting,” said David Nicholson, Executive Vice President and President Global Brands Research and Development, Allergan.

“DALVANCE is an important part of Allergan’s anti-infective portfolio focused on addressing infections in multiple clinical settings to help improve outcomes for patients and the healthcare system.”

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 (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).

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.

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.

Allergan about Dalvance

DALVANCE for injection is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone.  DALVANCE is the first and only IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes. DALVANCE demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.  On May 23, 2014 the FDA approved DALVANCE for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

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