Last week, Durata Therapeutics, Inc. (Nasdaq:DRTX) announced that DALVANCE (dalbavancin) for injection is now available for use to treat adult patients with acute bacterial skin and skin structure infections (ABSSSI). DALVANCE was approved by the U.S. Food and Drug Administration (FDA) on May 23, 2014 and was the first drug approved as a Qualified Infectious Disease Product (QIDP). Durata began shipping DALVANCE to its distributors earlier this week.
“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,” said Paul R. Edick, Durata’s CEO. “We are very pleased that DALVANCE is now available to millions of Americans who may benefit from this innovative treatment option for ABSSSI.”
For the six-month period of January to June 2010, a projected 9.2 million patients were treated in U.S. hospitals for infections of any type, and nearly 17 percent of the diagnostic category presentations were for skin and skin structure infections (SSSI). Of these presentations for SSSI, approximately 74 percent were disease types included in ABSSSI. This category of infection increased by 176 percent from 1997 to 2009 in hospitalized patients. The majority of skin and soft tissue infections in hospitalized patients are caused by Staphylococcus aureus, and approximately 59 percent of these infections are estimated to be caused by MRSA in the U.S. Effective early treatment of ABSSSI is critical to prevent wound expansion and to avoid lengthy and costly hospital stays. Failure to successfully treat ABSSSI may result in hospital readmissions.
“Managing the daily treatment of ABSSSI can be a difficult task for hospitals, physicians and patients,” said John Shannon, Durata’s Chief Commercial Officer. “We are very proud and excited to have hired, trained, and deployed over 100 outstanding commercial professionals to communicate the value of DALVANCE and its unique once-a week dosing for two weeks.”