Cubist Pharmaceuticals has announced that its new drug application (NDA) for tedizolid phosphate (TR-701) has been accepted by the US Food and Drug Administration (FDA) for priority review.
TR-701 is for the treatment of acute bacterial skin and skin structure infections (ABSSSI).
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The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 20 June 2014 under priority review.
Tedizolid phosphate is a once-daily oxazolidinone being developed for both intravenous (IV) 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 III clinical studies of tedizolid in ABSSSI, which met the primary and secondary endpoints defined by the FDA and the European Medicines Agency (EMA).
In 2013, the tedizolid obtained designation as a qualified infectious disease product (QIDP) from the FDA for its potential indication in ABSSSI.
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By GlobalDataThe QIDP designation has allowed the company certain incentives related to the development of new antibiotics, including eligibility for priority review and a five-year extension of Hatch-Waxman exclusivity should tedizolid phosphate be approved by the FDA.
Cubist Pharmaceuticals executive vice-president R&D and chief scientific officer Dr Steven Gilman said: "If approved, we expect tedizolid will address the serious public health threat of MRSA and offer a new treatment option for patients."
The company anticipates submitting a marketing authorisation application (MAA) for tedizolid to the EMA in the ABSSSI indication in the first half of 2014.
Cubist also hopes to submit a new drug submission (NDS) to Health Canada in the same timeframe.
Image: Scanning electron micrograph of Methicillin-resistant Staphylococcus aureus. Photo: courtesy of MattKingston.
