MRSA

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).

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

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).

"If approved, we expect tedizolid will address the serious public health threat of MRSA and offer a new treatment option for patients."

In 2013, the tedizolid obtained designation as a qualified infectious disease product (QIDP) from the FDA for its potential indication in ABSSSI.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The 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.