EMA’s CHMP Recommends Merck’s Antibiotic
Merck & Co. reports 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. The drug is approved in the US and is indicated for the treatment of 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.
Source: Merck & Co. .