Label Expansion for Skin Infection Drug Dalvance Under Review

The FDA is considering expanding the use of Allergen’s skin infection drug dalbavancin (Dalvance).

The supplemental New Drug Application (sNDA) expands Dalvance’s label to include a single-dose administration to treat acute bacterial skin and skin-structure infections (ABSSSI) that are caused by designated susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The sNDA was based on data from a phase 3 study that compared a single 1500-mg dose of Dalvance with a 2-dose regimen of 100 mg, followed 1 week later by a 500-mg dose.

In the study, Dalvance met its primary endpoint of non-inferiority to the 2-dose regimen at 48 to 72 hours after initiation of therapy, based on a decrease of at least 20% in the lesion area compared with the baseline measurement.

"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 of Global Brands Research and Development at Allergan, in a press release. "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 health care system."

Common adverse reactions to Dalvance include nausea, headache, and diarrhea.

In addition, serious hypersensitivity and skin reactions have been reported with glycopeptide antibacterial agents, including Dalvance.