FDA approves Durata’s Dalvance to treat skin infections

The US Food and Drug Administration last Friday approved Durata Therapeutics’ (Nasdaq: DRTX) Dalvance (dalbavancin), a new antibacterial drug used to treat adults with skin infections.

Dalvance, which is the first drug approved for Durata, is intended to treat acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria like Staphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains) and Streptococcus pyogenes. The treatment is administered intravenously.

Dalvance is the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Dalvance was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat serious or life-threatening infections.