Durata's landmark Qualified Infectious Disease Product launches in U.S.
- Injectable Dalvance is approved for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
- Dalvance is a second-generation semi-synthetic lipoglycopeptide.
- Injectable Dalvance has a convenient and unique dosing regimen and is the first FDA-approved ABSSSI therapy. Treatment involves a two-dose regimen of 1000 mg administered over a 30-minute period, followed by a 500-mg dose one week later that is also given over a 30-minute period.
According to the FDA, in order for a drug to be considered a Qualified Infectious Disease Product (QIDP), the “qualifying pathogen” has to be one with “the potential to pose a serious threat to public health.” Dalvance slows in vitro activity against a range of gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) and various Streptococcus species. As of June 18, 2013, the FDA had compiled a list of 18 qualifying pathogens -- many which are treatable with Dalvance.
According to Durata CEO Paul Edick, Dalvance's unique dosing regimen offers a new approach to treatment of serious skin infections by allowing patients, healthcare professionals and hospitals to move beyond the standard daily or twice-daily IV antibiotic infusions. "We are very pleased that DALVANCE is now available to millions of Americans who may benefit from this innovative treatment option for ABSSSI," said Edick.
Durata began shipping Dalvance to distributors earlier this week.
- Pharmaceutical Business Review Durata Therapeutics launches DALVANCE for injection in US