FDA to Review Allergan’s sNDA for New Dalvance Dosing

October 15, 2015

The FDA has agreed to review Allergan’s sNDA for a new single-dose regimen of its intravenous antibiotic Dalvance.

The once-weekly drug — which targets acute bacterial skin and skin structure infections, including staph infections like MRSA — is currently administered via a 1000 mg dose followed a week later by a 500 mg dose.

The sNDA draws on Phase 3 results of a study comparing the efficacy of a single 1500 mg dose with the approved dosing regimen. The study met its primary endpoint of 10 percent noninferiority within 48 to 72 hours. Patients in the once-dosed arm saw their lesions decrease by more than 20 percent, compared with baseline.

Dalvance — a lipoglycopeptide indicated to combat infections caused by Gram-positive bacteria — was the first drug approved under the FDA’s Qualified Infections Disease Product designation. It is the only IV antibiotic approved for treating ABSSSI, according to Allergan. — Victoria Pelham