WEDNESDAY, SEPTEMBER 28, 2016

Intravenous antibiotic oritavancin approved for priority review by FDA

The Medicines Company said on Wednesday that the U.S. Food and Drug Administration accepted its drug application for the investigational intravenous antibiotic oritavancin with priority review.

The medication is used to treat acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus.


"We look forward to working with the FDA during the review process, and sharing the knowledge we have gained in our studies of oritavancin," The Medicines Co. Vice President and Medical Director of infectious disease care Matthew Wikler said. "We believe that upon approval, oritavancin, administered as a single dose for the treatment of ABSSSI, will offer new options for both physicians and their patients for the treatment of these infections."


The FDA designated oritavancin as a Qualified Infectious Disease Product in December, which gives the drug priority review to be completed in six months instead of the standard 10 months.


Phase 3 trials of the drug tested the efficacy of a single 1200mg dose in comparison to seven to 10 days of twice-daily vancomycin in adults. The study was completed with 1,959 patients, with 405 suffering from a MRSA-confirmed ABSSSI.


In clinical trials, the most common side effects of the drug were nausea, headache, vomiting and diarrhea.


The Medicines Company works to provide medical solutions for acute cardiovascular care, surgery and perioperative care and serious infections disease care.