S aureus

The European Medicines Agency (EMA) has accepted The Medicines Company’s (MDCO) investigational intravenous antibiotic, oritavancin, for review of a marketing authorisation application (MAA).

Oritavancin is indicated for the treatment of complicated skin and skin tissue infections (cSSTI) caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.

Go deeper with GlobalData

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

cSSTI are also known as acute bacterial skin and skin structure infections (ABSSSI).

According to MDCO, acceptance of the MAA marks the beginning of the review process in the European Union (EU) for oritavancin.

The MAA is based on data secured from two Phase III clinical trials, which include SOLO I and SOLO II.

The trials assessed the efficacy and safety of a single 1,200mg dose of oritavancin compared with seven to ten days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA.

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.

According to the company, the combined SOLO trials were conducted in 1,959 patients (modified intent-to-treat population, or mITT), with 405 of the patients suffering from a cSSTI with a documented MRSA infection.

Tests showed that the most frequently reported adverse events related with oritavancin were nausea, headache, vomiting and diarrhoea.

The company said that hypersensitivity reactions have been reported with the use of antibacterial agents, including oritavancin.

In February, the US Food and Drug Administration has accepted the filing of MDCO’s new drug application (NDA) for oritavancin with priority review.

The NDA is based on data from the combined SOLO trials which were carried out under a special protocol assessment (SPA) agreement with the FDA.

Image: Scanning electron micrograph of S aureus. Photo: courtesy of Raeky.