FDA Panel Recommends Cubist's Sivextro For Acute Skin Infections

The U.S. Food and Drug Administration (FDA) Anti-Infective Drugs Advisory Committee (AIDAC) recommended approval of Cubist’s investigational antibiotic SIVEXTRO (tedizolid phosphate) for acute bacterial skin and skin structure infections (ABSSSI).

The drug received a unanimous 14 – 0 decision based on substantial evidence establishing the safety and efficacy of Sivextro.

Steven GilmanEVP of Research and Development and CSO of Cubist Pharmaceuticals, said, “We are very pleased with the strong endorsement from AIDAC members, and recommendation of approval for tedizolid, now known in the U.S. as SIVEXTRO. 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 (ABSSSI) are infections affecting deeper tissue, requiring surgical intervention. These diseases can also be associated with a significant underlying disease, such as diabetes, that complicates patient response to therapy. ABSSSI are also known as complicated skin and soft tissue infections (cSSTI) in Europe. While a range of pathogens may be implicated in ABSSSI/cSSSTI, the two most common Gram-positive pathogens are Staphylococcus aureus and Streptococcus pyogenes. The rising incidence of methicillin-resistant Staphylococcus aureus (MRSA) healthcare-associated infections (HAIs) has necessitated effective therapies against MRSA.

Sivextro is a once daily oxazolidinone being developed by Cubist for both intravenous and oral administration to treat serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Tedizolid phosphate is a novel oxazolidinone antibiotic drug candidate designed for rapid conversion in vivo by phosphatases to the microbiologically active moiety TR-700. TR-700 works to inhibit protein synthesis by binding to the bacterial 50S ribosomal subunit.

The New Drug Application (NDA) for Sivextro was supported by positive data from two global Phase III studies, which achieved both its primary and secondary endpoints as defined by the FDA and EMA.