FDA accepts Cubist Pharmaceuticals' tedizolid phosphate NDA with Priority Review

Dec 30 2013

Cubist Pharmaceuticals, Inc. (NASDAQ:CBST) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its investigational antibiotic tedizolid phosphate (TR-701) with Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of June 20, 2014. Cubist is seeking FDA approval of tedizolid for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

Tedizolid phosphate is an oxazolidinone being developed for both intravenous (I.V.) and oral administration for the treatment of serious Gram-positive infections, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The NDA submission is based on positive data from two global Phase 3 clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints defined by the FDA and the European Medicines Agency (EMA).

Earlier in 2013, the FDA designated tedizolid as a Qualified Infectious Disease Product (QIDP), according to the Generating Antibiotic Incentives Now (GAIN) Act, for its potential indication in ABSSSI. The QIDP designation for tedizolid phosphate has allowed for certain incentives related to the development of new antibiotics, including eligibility for Priority Review and, if tedizolid phosphate is ultimately approved by the FDA, a five year extension of Hatch-Waxman exclusivity.

"We are pleased to receive NDA acceptance for tedizolid, and look forward to working closely with the Agency on this Priority Review," said Steven Gilman, Ph.D., Executive Vice President of Research and Development and Chief Scientific Officer of Cubist Pharmaceuticals. "If approved, we expect tedizolid will address the serious public health threat of MRSA and offer a new treatment option for patients with serious skin infections."

During the first half of 2014 Cubist expects to submit a Marketing Authorization Application (MAA) for tedizolid to the EMA in the ABSSSI indication. Cubist is also expecting to submit a New Drug Submission (NDS) to Health Canada in the same timeframe.