Merck Sharp and Dohme’s new antibiotic recommended for EU approval

Merck Sharp and Dohme has announced that its new antibiotic product Sivextro has been recommended for European regulatory approval.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion endorsing approval of the antibiotic in the treatment of acute bacterial skin and skin structure infections in adults.

A once-daily oxazolidinone antibiotic developed for both intravenous and oral administration, Sivextro was acquired by Merck as part of its takeover of Cubist Pharmaceuticals. It is intended for the treatment of serious infections caused by certain Gram-positive bacteria.

It has already been approved for use in the US and is used to combat a number of dangerous bacterial strains, including the superbug MRSA.

The CHMP's positive opinion will now be reviewed by the European Commission. If the recommendation is upheld, the regulator will grant a centralised marketing authorisation with unified labelling that is valid in the 28 EU countries.

During 2014, Merck Sharp and Dohme generated global sales worth $42.24 billion (27.71 billion pounds), making it one of the world's largest pharmaceutical companies.