FDA approves new IV antibacterial drug used to treat adults with skin infections

FDA has approved dalbavancin (Dalvance, Durata Therapeutics) for injection 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).

Dalvance is the first and only IV antibiotic approved for the treatment of ABSSSI with a 2-dose regimen of 1,000 mg followed 1 week later by 500 mg, each administered over 30 minutes. It is also the first drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. 

“The FDA approval of Dalvance is recognized as the first once-weekly IV antibiotic for skin infections that will afford patients with an another therapeutic option to treat the more severe and drug-resistant infections,” said Abimbola Farinde, PharmD, MS, who serves on the faculty at Columbia Southern University, Orange Beach, Ala.

Dalvance’s safety and efficacy were evaluated in 2 clinical trials with a total of 1,289 adults with ABSSSI. Participants were randomly assigned to receive Dalvance or vancomycin. Results showed Dalvance was as effective as vancomycin for the treatment of ABSSSI.

Nausea, headache, and diarrhea were the most common side effects identified in the clinical trials. In the trials, more participants in the Dalvance group had elevations in 1 of their liver enzyme tests. The Dalvance drug label provides recommendations on dosage adjustment in patients with renal impairment.

For the 6-month period of January to June 2010, a projected 9.2 million patients were treated in US hospitals for infections of any type, and nearly 17% of the diagnostic category presentations were for skin and skin structure infections (SSSI). Of these presentations for SSSI, approximately 74% were disease types included in ABSSSI. This category of infection increased by 176% from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59% of these infections are estimated to be caused by MRSA in the United States, according to a Durata press release.