CHMP recommends Sivextro for ABSSSI

EMA's CHMP recommended marketing authorization of oral and IV Sivextro tedizolid from Merck & Co. Inc. (NYSE:MRK) to treat acute bacterial skin and skin structure infections (ABSSSI) in adults. CHMP said the authorization would include a pharmacovigilance plan. Merck obtained rights to Sivextro earlier this week when it completed its acquisition of Cubist Pharmaceuticals Inc. (see BioCentury, Dec. 15, 2014).

FDA approved the second-generation oxazolidinone that inhibits bacterial protein biosynthesis last June to treat ABSSSI caused by susceptible bacteria, including methicillin-resistant Staphylococcus aureus (MRSA) (see BioCentury Extra, June 20, 2014). ...