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news.Durata Therapeutics has received approval from the US Food and Drug Administration (FDA) for its Dalvance (dalbavancin) injection to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
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Dalvance is the first and only IV antibiotic approved to treat ABSSSI with a two-dose regimen of 1000mg followed one week later by 500mg, each administered over 30 minutes.
It is a second generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone.
The drug shows bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.
Durata Therapeutics chief executive officer Paul Edick said the company is happy to bring Dalvance to market for the millions of Americans who may benefit from an innovative treatment option for ABSSSI in today’s evolving health care environment.
"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," Edick said.
"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."
The approval is based on the entire Dalvance clinical program which included 21 clinical trials with five Phase III trials evaluating about 3,000 patients.
Two Phase III trials, DISCOVER 1 and DISCOVER 2, were carried out under a Special Protocol Assessment (SPA) with the FDA and included over 1,300 patients with ABSSSI.
The trials showed Dalvance was non-inferior to the comparator regimen and met its primary and secondary endpoints of early response, measured at 48 to 72 hours of therapy, and clinical success at the end of treatment in patients with very large skin lesions and high frequencies of fever.
Image: Dalvance for injection is approved for the treatment of ABSSSI with a two-dose regimen of 1000mg followed one week later by 500mg, each administered over 30 minutes. Photo: courtesy of antpkr/freedigitalphotos.net