Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued positive opinion recommending approval for Merck's investigational antibiotic Sivextro (tedizolid phosphate) to treat acute bacterial skin and skin structure infections (ABSSSI) in adults.
Subscribe to our email newsletter
The company acquired Sivextro, as a part of its purchase through a subsidiary of Cubist Pharmaceuticals.
Sivextro is a once-daily oxazolidinone antibiotic developed for both intravenous and oral administration to treat serious infections caused by certain Gram-positive bacteria.
The CHMP positive opinion will be reviewed by the European Commission, following which it will grant a centralized marketing authorization with unified labeling that is valid in the 28 countries that are members of the EU, as well as European Economic Area members, Iceland, Liechtenstein and Norway.
In the US, Sivextro is approved to treat ABSSSI caused by susceptible isolates of the following Gram-positive microorganisms: Staphylococcus aureus, Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus anginosus group, and Enterococccus faecalis.
The company said that the most common adverse reactions for Sivextro are nausea, headache, diarrhea, vomiting and dizziness.