FDA Approves Cubist Pharmaceuticals’ Skin Antibacterial Drug

The US Food and Drug Administration (FDA) today approved Cubist Pharmaceuticals’ Sivextro (tedizolid phosphate), a new antibacterial drug to treat adults with skin infections.

Sivextro is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, including Staphylococcus aureus (including methicillin-resistant strains (MRSA) and methicillin-susceptible strains), various Streptococcus species, and Enterococcus faecalis. Sivextro is available for intravenous and oral use.

Sivextro was designated  by FDA 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 Sivestro for certain incentives related to the development of new antibiotics, including a five-year extension of Hatch-Waxman exclusivity.

Sivextro is under review by the European Medicines Agency for treating complicated skin and soft tissue infections. A decision from the European Commission is expected during the first half of 2015. Clinical studies are also ongoing for the potential use of the drug in the treatment of hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia.

Sivextro is the second new antibacterial drug approved by the FDA in the past month to treat ABSSSI. On May 23, the agency approved Durata Therapeutics’ Dalvance (dalbavancin), also to treat patients with ABSSSI caused by Staphylococcus aureus and various Streptococcus species.

Source: FDA and Cubist Pharmaceuticals

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