Cubist's Anti-Bacterial Drug Sivextro Now Available in U.S.
By C. Rajan, contributing writer
Cubist Pharmaceuticals announced last week that its anti-bacterial drug, Sivextro (Tedizolid phosphate), indicated for the treatment of adult acute bacterial skin and skin structure infections (ABSSSI) is now available in the U.S. in once-daily I.V. and oral formulations.
Sivextro is a short, six-day course of therapy to treat serious skin infections. Sivextro is a novel oxazolidinone molecule with in vitro activity against clinically significant susceptible Gram-positive pathogens. The therapy is administered once-daily. Approved by the U.S. FDA in June 2014, Sivextro addresses ABSSSI caused by susceptible Gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).
“We are pleased to formally announce the availability of the I.V. version of Sivextro for physician and hospital order in the U.S.,” said Rob Perez, President and COO of Cubist. “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.”
Sivextro has been accepted for review in the EU, where Cubist is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). Acute bacterial skin and skin structure infections (ABSSSI) are also referred to as complicated skin and soft tissue infections (cSSTI) (in Europe). A decision from the European Commission is expected during the first half of 2015.
Sivextro's FDA approval was supported by two Phase 3 studies, which showed that it was statistically non-inferior to 600 mg of Pfizer's Zyvox (linezolid) taken twice a day for 10 days. 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).
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 qualified Sivextro for certain incentives related to the development of new antibiotics, including a five year extension of exclusivity.
According to the U.S. Centers for Disease Control and Prevention (CDC), each year more than two million Americans develop infections from antibiotic-resistant bacteria. One of the serious public health threats is methicillin-resistant Staphylococcus aureus (MRSA), which continues to be a clinical and economic burden. According to the CDC, there are approximately 80,000 severe MRSA infections and 11,000 deaths from MRSA in the U.S. per year.
Sivextro is expected to become Cubist's blockbuster drug with estimated annual sales of over $300 million. Cubist is aiming to launch at least three more anti-bacterial drugs by 2020.