FDA Committee Recommends Cubist's Sivextro For Serious Skin Infections
By Cyndi Root
Cubist Pharmaceuticals, Inc. announced in a press release that a Food and Drug Administration (FDA) committee has recommended approval its investigational antibiotic Sivextro (tedizolid phosphate). The Anti-Infective Drugs Advisory Committee (AIDAC) voted unanimously in 14-0 decision, that there is enough evidence of safety and effectiveness for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
Committee recommendations are not binding, but the FDA values it opinion along with clinical trial data and pharmokinetic studies. The FDA is expected to make a decision by June 20, 2014.
Steven Gilman, EVP of Research at Cubist Pharmaceuticals said, “We are encouraged by the recognition that there is a need for more treatment options for patients to address serious skin infections. We look forward to the FDA’s final review of Sivextro and decision.”
Acute Bacterial Skin and Skin Structure Infections
Acute bacterial skin and skin structure infections (ABSSSI) are a growing problem worldwide. These serious infections often require surgery because they occur in deep tissues. Some infections are due to an underlying disease while others develop due to cellulitis, abscesses, and infected wounds. Certain pathogens are associated with these infections including Staphylococcus aureus and Streptococcus pyogenes. Methicillin-resistant Staphylococcus aureus (MRSA), healthcare-associated infections (HAIs), and community infections are on the rise, spurring a need for new treatments.
Sivextro
Sivextro (tedizolid phosphate) is in the oxazolidinone class. The oxazolidinones inhibit bacterial protein synthesis.Cubist is developing Sivextro for oral administration and intravenous (IV) use.
Cubist based its New Drug Application (NDA) on Phase 3 clinical studies in which the study endpoints, defined by the FDA and European Medicines Agency (EMA), were met. The clinical trials in the U.S., Europe, and other sites worldwide showed that Sivextro was non-inferior to linezolid. Adverse event rates were similar between the two drugs and included diarrhea, nausea, and vomiting.
About Cubist
Cubist Pharmaceuticals has several approved antibiotics for conditions such as complicated skin and skin structure infections (cSSSI), Staphylococcus aureus bacteremia, clostridium difficile-associated diarrhea (CDAD), and accelerated GI recovery following surgeries that include partial bowel resection with primary anastomosis infections.