EMA accepts Cubist's tedizolid MAA for review

Saturday, March 01, 2014, 11:00 Hrs  [IST]

The European Medicines Agency (EMA) has accepted to review Cubist Pharmaceuticals' Marketing Authorization Application (MAA) for its investigational antibiotic tedizolid phosphate. Cubist is seeking approval of tedizolid for the treatment of complicated skin and soft tissue infections (cSSTI), with a decision from the European Commission (EC) expected during the first half of 2015. Tedizolid is a once daily oxazolidinone being developed for both intravenous (IV) and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The MAA submission is based on positive data from two global phase III clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and US Food and Drug Administration (FDA). “We are very pleased to receive MAA acceptance for tedizolid and to work with the EMA on this important review process,” said Steve Gilman, executive vice president of Research and Development and chief scientific officer of Cubist Pharmaceuticals. “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.” Prior to the EMA acceptance of the MAA, the FDA accepted the Company’s New Drug Application (NDA) for tedizolid with Priority Review and assigned an action date of June 20, 2014. The FDA has asked Cubist to participate in a meeting of its Anti-Infective Drugs Advisory Committee (AIDAC) on March 31, 2014. The AIDAC will review data supporting the Company’s NDA for tedizolid, for which Cubist is seeking approval in acute bacterial skin and skin structure infections (ABSSSI). Additionally, Cubist expects to submit a New Drug Submission (NDS) to Health Canada during the first half of 2014 in acute bacterial skin and skin structure infections (ABSSSI). Complicated skin and soft tissue infections (cSSTI) and acute bacterial skin and skin structure infections (ABSSSI) are a significant and growing problem throughout the world. These infections involve deeper tissue or require surgical intervention (e.g., cellulitis, major cutaneous abscesses and infected wounds) or are associated with a significant underlying disease (e.g., diabetes or systemic immunosuppression) that complicates response to therapy. Cubist has a growing commitment to global public health through its leadership in the R&D of antibiotics to treat serious and life-threatening infections caused by a broad range of increasingly resistant bacteria. Cubist Pharmaceuticals, Inc. is a global biopharmaceutical company focused on the research, development, and commercialization of pharmaceutical products that address significant unmet medical needs in the acute care environment.