FDA Approves Durata's Dalvance For Skin Infections

Durata Therapeutics announced in a press release that the Food and Drug Administration (FDA) has approved Dalvance (dalbavancin). The antibiotic is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA). Dalvance was granted priority review as a Qualified Infectious Disease Product (QIDP).The approval follows a 12-0 vote by the FDA’s Anti-Infective Drugs Advisory Committee indicating positive support of the evidence that Dalvance is safe and effective.

Paul Edick, CEO of Durata Therapeutics, said, "Dalvance’s unique dosage regimen offers a new approach to treatment of these serious skin infections by allowing patients, health care professionals, and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions.” Edward Cox,director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, said in the FDA’s press release, that the approval demonstrates the FDA’s commitment to encouraging the development of new antibacterial drugs.

Dalvance

Dalvance (dalbavancin) has changed hands a few times. Vicuron Pharmaceuticals, introduced the drug to the FDA in 2004. Pfizer acquired Dalvance as an asset when it acquired Vicuron in 2005. Unconvinced of the drug’s promise, however, Pfizer chose to spin out the product to Durata.

Dalvance is a synthetic lipoglycopeptide, a second generation, semi-synthetic agent. It consists of a glycopeptide backbone with a lipophilic side-chain. The antibiotic has shown bactericidal activity in vitro against numerous gram-positive bacteria, including Staphylococcus aureus, Streptococcus pyogenes, and MRSA (methicillin-resistant Staphylococcus aureus).

Dalvance Clinical Trials

The drug has been tested in 21 trials on over 3,000 patients, including the 1,300 in the DISCOVER 1 and DISCOVER 2 (Dalbavancin for Infections of the Skin Compared to Vancomycin at an Early Response) Phase III trials. In the Phase III trials, patients with ABSSSI took dalbavancin or vancomycin intravenously. The trials found that Dalvance was non-inferior to the comparator agent. It met its primary endpoint of an early response to treatment (48 to 72 hours). In patients with large skin lesions and high frequencies of fever, Dalvance improved fever and redness (erythema).

ABSSSI

Acute bacterial skin and skin structure infections (ABSSSI) affect about 2 million people each year, and those cases have risen dramatically in the last several years. From 1997 to 2009, ABSSSI rates have risen by 176 percent. Most infections are caused by Staphylococcus aureus, and about two thirds of those infections are caused by MRSA. Effective treatment administered early can prevent long hospital stays, worsening outcomes, and hospital readmissions.