Medicines Company's antibiotic receives QIDP designation
The U.S. Food and Drug Administration granted the designation, which provides priority FDA review, eligibility fast track status and an added five years of exclusivity upon approval for oritavancin. The QIDP designation was granted pursuant to the Generating Antibiotic Incentives Now Act.
The Medicines Company plans to submit a new drug application to the FDA for the use of oritavancin in the treatment of acute bacterial skin and skin structure infections caused by susceptible gram-positive bacteria in the fourth quarter of 2013.
"We believe a priority review and approval will help us bring oritavancin, a single dose treatment, to patients with ABSSSI more quickly," Matthew Wikler, the vice president medical director of anti-infectives solutions for The Medicines Company, said. "With oritavancin eligible for additional exclusivity, The Medicines Company can continue our planned development for oritavancin for the potential treatment of additional serious gram-positive bacterial infections."
The Medicines Company completed two Phase III clinical trials for oritavancin, one in December and the other in July. The trials represented the largest patient population ever evaluated for an anti-infective for the treatment of ABSSSI in controlled clinical trials. The trials found the most frequently reported adverse events associated with the investigational drug were diarrhea, vomiting, headache and nausea.
ABSSSI can be caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus.