European Medicines Agency recommends approval of Sivextro

The Committee for Medicinal Products for Human Use at the European Medicines Agency (EMA) recently recommended approval of Sivextro (tedlizolid phosphate), an antibiotic used to treat acute bacterial and skin structure infections from Gram-positive microorganisms.

Produced by Merck, Sivextro is a once-daily oxazolidinone investigational drug that is already approved in the Unites States to treat such Gram-positive microorganisms as Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group and Enterococcus faecalis. 

After the European Commission reviews the opinion, there will be a centralized marketing authorization for Sivextro that is valid for the 28 countries in the European Union and European Economic Area members Norway, Iceland and Liechtenstein.

Side effects of the medication include nausea, headache, vomiting and dizziness. If diarrhea occurs, caution should be taken to ensure Clostridium difficile-associated diarrhea is not the cause. The drug should only be used if a bacterial infection is proven or strongly suspected.

The treatment of patients with neutropenia has not been adequately evaluated and alternative methods of treatment should be considered.

Merck acquired Sivextro after its purchase of Cubist Pharmaceuticals Inc.