Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of the investigational antibiotic SIVEXTRO® (tedizolid phosphate) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Merck acquired SIVEXTRO as a part of its purchase, through a subsidiary, of Cubist Pharmaceuticals, Inc.
The CHMP positive opinion will be reviewed by the European Commission. If the European Commission affirms the CHMP opinion, it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the European Union, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
SIVEXTRO is a once-daily oxazolidinone antibiotic developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria.
SIVEXTRO in the U.S.
SIVEXTRO is approved in the U.S. and is indicated for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant [MRSA] and methicillin-susceptible [MSSA] isolates), Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group (including Streptococcus anginosus, Streptococcus intermedius and Streptococcus constellatus), and Enterococccus faecalis.
Selected Safety Information
Patients with neutropenia: The safety and efficacy of SIVEXTRO (tedizolid phosphate) in patients with neutropenia (neutrophil counts <1000 cells/mm3) have not been adequately evaluated. In an animal model of infection, the antibacterial activity of SIVEXTRO was reduced in the absence of granulocytes. Alternative therapies should be considered when treating patients with neutropenia and acute bacterial skin and skin structure infection.
Clostridium difficile-associated diarrhea (CDAD), ranging from mild diarrhea to fatal colitis, has been reported with nearly all systemic antibacterial agents, including SIVEXTRO. Evaluate all patients who present with diarrhea following SIVEXTRO use.
Development of drug-resistant bacteria: Prescribing SIVEXTRO in the absence of a proven or strongly suspected bacterial infection or prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria.
The most common adverse reactions for SIVEXTRO are nausea, headache, diarrhea, vomiting, and dizziness.
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Please see Prescribing Information for SIVEXTRO (tedizolid phosphate) at http://sivextro.com/pdf/sivextro-prescribing-info.pdf.
SIVEXTRO® is a registered trademark of Cubist Pharmaceuticals, Inc., a wholly-owned subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.