CHMP recommends Sivextro (tedizolid phosphate) treatment of ABSSSI- Merck Inc.

Merck has 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 of Cubist Pharmaceuticals. 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 is approved in the USA and is indicated for the treatment of ABSSSI.

Comment: Sivextro will compete with Zyvox (linezolid) from Pfizer which is due to lose patent protection in 2015. Sivextro will have an advantage over forthcoming generics as it can be taken once a day for six days versus twice daily for over two weeks for Zyvox. Sivextro is seen as being as effective as Zyvox but is not superior. It has fewer side effects, less frequent dosing and a shorter duration of treatment time.