CHICAGO, Sept. 26, 2013 (GLOBE NEWSWIRE) -- Durata Therapeutics, Inc. (Nasdaq:DRTX), an emerging specialty pharmaceutical company, today announced that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of dalbavancin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive microorganisms, including MRSA (methicillin resistant Staphylococcus aureus).
"We are pleased to be another step closer to offering dalbavancin for the treatment of patients with acute bacterial skin and skin structure infections," said Paul R. Edick, Durata Therapeutics Chief Executive Officer. "Dalbavancin is our first product candidate, and this milestone demonstrates our company's commitment to improving patients' lives by addressing the growing demand for therapeutics to treat acute illnesses and infectious diseases."
The submission is based on the entire data set from Durata Therapeutics' clinical development program, including positive results from two Phase 3 trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase 3 study (VER-009). Both DISCOVER 1 and DISCOVER 2 trials were conducted under a Special Protocol Assessment (SPA) with the FDA.In November 2012, the FDA designated dalbavancin as a Qualified Infectious Disease Product (QIDP). The QIDP provides Durata Therapeutics priority review by the FDA, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years upon FDA approval of the product. "Currently available treatments for ABSSSI have limitations, especially in today's health care environment, so the development of new antibiotics is imperative," said David Andrew Talan, MD, FACEP, FIDSA Chairman, Department of Emergency Medicine and Faculty, Division of Infectious Diseases. "If approved by the FDA, dalbavancin, with its once-weekly 30-minute intravenous doses, may help facilitate an important shift in treatment from the hospital to ambulatory settings."