Cubist Pharma Says EMA Accepts MAA For Tedizolid For Review - Quick Facts

(RTTNews) - Cubist Pharmaceuticals, Inc. (CBST) reported that the European Medicines Agency or EMA has accepted the company's Marketing Authorization Application or MAA for its investigational antibiotic tedizolid phosphate for review. The company is seeking approval of tedizolid to treat complicated skin and soft tissue infections or cSSTI, with a decision from the European Commission or EC anticipated in the first half of 2015.

Tedizolid is a once daily oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus. The MAA submission is based on positive data from two global Phase 3 trials of tedizolid, that achieved the primary and secondary endpoints defined by the EMA and U.S. Food and Drug Administration or FDA.

Prior to the EMA acceptance of the MAA, the FDA accepted the firm's New Drug Application or NDA for tedizolid with Priority Review and assigned an action date of June 20, 2014. Further, Cubist may submit a New Drug Submission to Health Canada in the first half of 2014 in acute bacterial skin and skin structure infections.