Durata Therapeutics has submitted a new drug application (NDA) to the US Food and Drug Administration (FDA) seeking approval for dalbavancin for the treatment of patients with acute bacterial skin and skin structure infections (ABSSSI).
The NDA submission follows the company’s clinical development programme, including positive results from two Phase III trials DISCOVER 1 and DISCOVER 2, as well as a previous Phase III study (VER-009).
Pharmaceutical firm Durata conducted both DISCOVER 1 and DISCOVER 2 trials under a special protocol assessment (SPA) with the FDA.
In November 2012, the FDA designated dalbavancin as a qualified infectious disease product, which provides Durata priority review by the agency, eligibility for fast-track status, and extension of statutory exclusivity periods for an additional five years after the product’s approval.
Durata said dalbavancin is a second generation, semi-synthetic lipoglycopeptide, which features lipophilic side-chains attached to glycopeptides.
According to the company, when compared with vancomycin, dalbavancin has a longer half-life resulting in a duration of antibacterial activity of five to seven days per dose.
The company claims that if approved, dalbavancin would be the first drug for ABSSSI requiring once-weekly 30-minute intravenous doses, which may allow for the treatment of patients with ABSSSI in both inpatient and outpatient settings.
Durata Therapeutics chief executive officer Paul Edick said: "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."
Image: Dalbavancin will be used for the treatment of patients with acute bacterial skin and skin structure infections. Photo: courtesy of FreeDigitalPhotos.net.