Cubist gets FDA approval for Sivextro to treat serious skin infections

The drug addresses ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), which has been categorized as a serious public health threat by the US Centers for Disease Control and Prevention (CDC).

Sivextro, which should be administered once daily, provides an effective, short six-day course of therapy.

It is a new oxazolidinone with in vitro activity against clinically significant susceptible Gram-positive pathogens including MRSA.

The company said that the drug is now approved in both an intravenous (I.V.) and oral formulations.

The approval of the New Drug Application (NDA) for Sivextro was based on two global Phase III trials, which met primary and secondary endpoints defined by the FDA as well as the European Medicines Agency (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.

Cubist chief executive officer Michael Bonney said that the company is happy by the FDA approval of Sivextro, which provides a new option for physicians to treat patients with serious bacterial skin infections, including those caused by MRSA.

"Sivextro provides physicians with flexibility to transition patients from I.V. to oral treatment as required," Bonney said.

"The oral option provides opportunity for out-patient care, which could reduce the need for costly hospitalization.

"In addition, Sivextro is one of at least four antibiotics Cubist hopes to deliver in support of the Infectious Diseases Society of America challenge to industry and policy makers to develop and approve 10 new antibiotics by 2020."

Image: Cubist’s Sivextro is now approved in both an intravenous and oral formulations. Photo: foto76