Cubist's Sivextro Approved By FDA For Skin Infections
Lexington-based biotech Cubist Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has granted approval for Sivextro (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI). The drug is available for intravenous and oral use.
Sivextro is a new antibacterial indicated for the treatment of ABSSSI, in particular those caused by susceptible Gram-positive bacteria including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis.
The NDA for Sivextro was supported by positive data from two clinical trials involving 1,315 adults with ABSSSI, where the drug showed on par performance to linezolid. The FDA designated Sivextro a qualified infectious disease product (QIDP) and granted the drug an expedited review.
Michael Bonney, CEO of Cubist, said the company was delighted with the FDA approval. “SIVEXTRO provides physicians with flexibility to transition patients from I.V. to oral treatment as required. 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.”
ABSSSI, also known as complicated skin and soft tissue infections (cSSTI) in Europe, are a growing health problem around the world. The skin infections involve deeper tissue or require surgical intervention. These are often linked with a significant underlying disease that makes response to therapy more complicated. The U.S. Centers for Disease Control and Prevention (CDC) has categorized ABSSSI and MRSA as a serious public health threat.
Ralph Corey, Professor of Medicine and Infectious Disease at Duke Clinical Research Institute and Duke University Medical Center, said, “MRSA is still problematic in the U.S. and is responsible for the deaths of more than 11,000 Americans each year. Not every antibiotic will work for every patient and more drug options are an imperative. Physicians should evaluate the use of SIVEXTRO. A six-day course of therapy with the option to choose—and, if needed—change from I.V. to oral administration is a welcome new development.”
A Marketing Authorization Application (MAA) for Sivextro is currently under review by the EMA, for which the company expects a decision by the first half of 2015.