FDA has approved Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI). Sivextro addresses ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), which has been categorized by the US Centers for Disease Control and Prevention (CDC) as a serious public health threat.
On March 31, 2014 an FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of Sivextro. In the unanimous decision, the AIDAC found that substantial evidence of the safety and effectiveness of Sivextro for the treatment of ABSSSI was provided.
Sivextro is administered once daily for a short, six-day course of therapy. Sivextro is a oxazolidinone with in vitro activity against clinically significant susceptible Gram-positive pathogens including MRSA and is now approved in both intravenous and oral formulations.
Sivextro is one of the first medicines approved in the US that FDA designated as a Qualified Infectious Disease Product (QIDP) for its indication, ABSSSI, according to the Generating Antibiotic Incentives Now Act of 2012. The QIDP designation qualifies Sivextro for certain incentives related to the development of new antibiotics, including a five-year extension of Hatch-Waxman exclusivity.
"MRSA is still problematic in the US and is responsible for the deaths of more than 11,000 Americans each year," said Ralph Corey, MD, Professor of Medicine and Infectious Disease, Duke Clinical Research Institute and Duke University Medical Center, in the press release. "Not every antibiotic will work for every patient and more drug options are an imperative."