Lexington-based Cubist Pharmaceuticals Inc. said Thursday that European regulators have accepted for review the marketing authorization application, or MAA, for an investigational antibiotic that can treat complicated skin and soft tissue infections.
A decision by the European Medicines Agency on an antibiotic called tedizolid is expected “during the first half of 2015,” Cubist said in a press release.
Previously, the US Food and Drug Administration accepted Cubist’s new drug application for tedizolid with Priority Review and assigned an action date of June 20. The FDA has asked Cubist to participate in a meeting of its Anti-Infective Drugs Advisory Committee on March 31.
Steve Gilman, Cubist’s executive vice president of research and development and chief scientific officer, commented on the action of the European regulators in a statement included in Thursday’s release.
“We are very pleased to receive MAA acceptance for tedizolid and to work with the EMA on this important review process,” Gilman said. “As we continue to build out our global infrastructure, this is a significant development in our ongoing mission to advance potential new antibiotics for patients facing serious bacterial infections, such as MRSA, around the world.”