June 4, 2014
Qualified Infectious Disease Product Approved Under
Fast-Track Program

Washington, D.C.—The first drug designated as a Qualified Infectious Disease Product (QIDP) has received FDA approval and should be available in the third quarter of this year.

Dalbavancin, marketed as Dalvance by Durata Therapeutics of Chicago, is categorized as an antibacterial or antifungal human drug intended to treat serious or life-threatening infections. The FDA Safety and Innovation Act of 2012 established the Generating Antibiotic Incentives Now (GAIN) designation.

Dalvance, administered intravenously once weekly, was developed to treat acute bacterial skin and skin structure infections (ABSSSI) caused by specific susceptible bacteria such as Staphylococcus aureus—including methicillin-susceptible and methicillin-resistant—and Streptococcus pyogenes.

“Today’s approval demonstrates the FDA’s commitment to encouraging increased development and approval of new antibacterial drugs, providing physicians and patients with important new treatment options,” noted Edward Cox, MD, MPH, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

“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,” said Durata Therapeutics CEO Paul R. Edick. “We are executing on all fronts to complete the necessary activities required to launch and ensure success. The time to build out and train a first-class salesforce, complete packaging and final qualification activities keeps us on track to begin shipping in the third quarter.”

Dalvance’s QIDP designation allowed it priority review, which expedited the drug’s application. QIDP designation also qualifies pharmaceuticals for an additional 5 years of marketing exclusivity beyond the FDA’s established periods. Edick pointed out that would mean 10 years of exclusivity in the United States, the same duration provided by regulatory agencies in Europe.

The antibacterial’s safety and efficacy were evaluated in two clinical trials with a total of 1,289 adults with ABSSSI. With participants randomly assigned to receive either Dalvance or vancomycin, Dalvance was shown to be as effective as vancomycin for the treatment of ABSSSI.

The most common side effects identified in the clinical trials were nausea, headache, and diarrhea. More study participants in the Dalvance group had elevations in one of their liver enzyme tests, however, and the drug’s label also provides recommendations on dosage adjustment in patients with renal impairment.

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