FDA approves Sivextro for treatment of Acute Bacterial Skin and Skin Structure Infections- Cubist Pharma

Cubist Pharmaceuticals, Inc. announced the FDA has on 20 June 2014 approved 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 U.S. Centers for Disease Control and Prevention (CDC) as a serious public health threat.

Administered once daily, Sivextro offers an effective, short six-day course of therapy. Sivextro is a novel oxazolidinone with in vitro activity against clinically significant susceptible Gram-positive pathogens including MRSA and is now approved in both an intravenous (I.V.) and oral formulations.

The New Drug Application (NDA) was supported by two global Phase III studies, which met primary and secondary endpoints defined by the FDA and the European Medicines Agency (EMA). These studies demonstrated that Sivextro 200 mg administered once daily for six days was statistically non-inferior to 600 mg of linezolid taken twice a day for 10 days. In these studies, the adverse event rates were similar for patients treated with Sivextro and linezolid. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups.

Sivextro is one of the first medicines approved in the U.S. that the FDA designated as a Qualified Infectious Disease Product (QIDP) for its indication, ABSSSI, according to the Generating Antibiotic Incentives Now (GAIN) 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.

The EMA has accepted for review Cubist’s Marketing Authorization Application (MAA) for Sivextro, for which the company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission is expected during the first half of 2015.