Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced today the U.S. Food and Drug Administration (FDA) approved SIVEXTRO™ (tedizolid phosphate) for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI). SIVEXTRO addresses ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), which has been categorized by the U.S. Centers for Disease Control and Prevention (CDC) as a serious public health threat.
Administered once daily, SIVEXTRO offers an effective, short six-day course of therapy. SIVEXTRO is a novel oxazolidinone with in vitro activity against clinically significant susceptible Gram-positive pathogens including MRSA and is now approved in both an intravenous (I.V.) and oral formulations.
The New Drug Application (NDA) for SIVEXTRO was supported by two global Phase 3 studies, which met primary and secondary endpoints defined by the FDA and the European Medicines Agency (EMA). These studies demonstrated that SIVEXTRO 200 mg administered once daily for six days was statistically non-inferior to 600 mg of linezolid taken twice a day for 10 days. In these studies, the adverse event rates were similar for patients treated with SIVEXTRO and linezolid. Gastrointestinal adverse events (diarrhea, nausea and vomiting) were the most commonly reported in both treatment groups.
SIVEXTRO is one of the first medicines approved in the U.S. that the FDA designated as a Qualified Infectious Disease Product (QIDP) for its indication, ABSSSI, according to the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies SIVEXTRO for certain incentives related to the development of new antibiotics, including a five year extension of Hatch-Waxman exclusivity.
"We are pleased 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," said Michael Bonney, Chief Executive Officer of Cubist. "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."
"MRSA is still problematic in the U.S. and is responsible for the deaths of more than 11,000 Americans each year," said Ralph Corey, M.D., Professor of Medicine and Infectious Disease, Duke Clinical Research Institute and Duke University Medical Center. "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."
"I am proud to have introduced the GAIN Act, which is one important piece of addressing the public health crisis of untreatable infections and drug-resistant pathogens," said Senator Richard Blumenthal (D-CT). "Today's announcement shows that we are starting to see new products enter the market - which is a promising step in addressing these life-threatening conditions. I look forward to working with my colleagues on other initiatives to continue the fight against deadly antimicrobial resistance."
On March 31, 2014 an FDA Anti-Infective Drugs Advisory Committee (AIDAC) voted to recommend approval of SIVEXTRO. In the unanimous 14 - 0 decision, the AIDAC found that substantial evidence of the safety and effectiveness of SIVEXTRO for the treatment of ABSSSI was provided.
Patients seeking assistance may be eligible for AccessSIVEXTRO.
The EMA has accepted for review Cubist'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). A decision from the European Commission is expected during the first half of 2015. Clinical studies are also ongoing for the potential use of SIVEXTRO in the treatment of hospital-acquired bacterial pneumonia (HABP)/ventilator-associated bacterial pneumonia (VABP).
Cubist Pharmaceuticals, Inc.