Durata Therapeutics (NASDAQ: DRTX) today announced that the U.S. Food and Drug Administration (FDA) has designated dalbavancin as a Qualified Infectious Disease Product (QIDP). The QIDP designation provides Durata 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 for the treatment of acute bacterial skin and skin structure infections (ABSSSI). Dalbavancin is Durata’s lead product candidate, currently under investigation for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including MRSA (methicillin resistant
Dalbavancin is among the first anti-infective agents to receive QIDP designation through the new Generating Antibiotic Incentives Now (GAIN) statute, created by Congress to encourage the development of therapies for drug-resistant organisms known to cause serious or life-threatening infections. The GAIN provisions are included in the FDA Safety and Innovation Act (FDASIA) that was signed into law by President Obama in July 2012.
“By expediting the FDA review process, the QIDP designation will help us bring dalbavancin to patients who face serious skin infections more quickly. QIDP status also complements the intellectual property protections provided by our underlying patents. If the FDA approves dalbavancin for the treatment of ABSSSI, we would receive 10 years of exclusivity in the U.S., the same duration provided by regulatory agencies in Europe,” said Durata Therapeutics CEO Paul R. Edick.
In September 2012 the FDA announced the formation of an internal task force “…that will support the development of new antibacterial drugs, a critical health care goal and a priority for the agency.” Durata continues to work closely with clinical investigators and the FDA with the goal of bringing dalbavancin to healthcare professionals and their patients by 2014.
Dalbavancin is an intravenous antibiotic product candidate under investigation for once-weekly dosing, which we believe may facilitate the treatment of patients with ABSSSI in both the in-patient and out-patient settings, potentially reducing the length of a patient’s hospital stay or avoiding hospital admission altogether, with an impact on the overall cost of care for these patients.