Sivextro is a short, six-day course therapy for the treatment of serious skin infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
The drug was approved by the US Food and Drug Administration (FDA) in June 2014 for the treatment of ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.
Cubist president and chief operating officer Rob Perez said the company is happy to formally announce the availability of the I.V. version of Sivextro for physician and hospital order in the US.
"SIVEXTRO oral has been on the market since late June. We believe the features and utility of SIVEXTRO offers physicians an effective option to treat acute bacterial skin and skin structure infections in a number of real-life patient settings — from the hospital to the home," Perez said.
The European Medicines Agency (EMA) has accepted for review the company’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).
The company expects a decision from the European Commission during the first half of 2015.
The NDA for Sivextro was based on two global Phase III trials, which met primary and secondary endpoints defined by the FDA and the EMA.
The trials showed that Sivextro 200mg administered once daily for six days was statistically non-inferior to 600mg of linezolid taken twice a day for 10 days.