TMC’s ABSSSI NDA Gets QIDP

The FDA has granted The Medicines Company Qualified Infectious Disease Product (QIDP) status for oritavancin. This designation provides oritavancin priority review by the FDA, eligibility for FDA’s Fast Track status, and an additional five years of exclusivity upon approval of the product for the treatment of acute bacterial skin and skin structure infections (ABSSSI).

The Medicines Company plans to submit a New Drug Application to the FDA in 4Q13 for the use of oritavancin in ABSSSI caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

The Medicines Company completed two Phase III clinical trials for oritavancin in December 2012 and July 2013, respectively. These trials evaluated the efficacy and safety of a single 1200mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA. The combined studies of 1,959 patients (modified intent-to-treat population, or mITT) represent the largest patient population ever evaluated for an anti-infective for the treatment of ABSSSI in controlled clinical trials. In addition, the combined trials have assessed one of the largest subsets of patients with documented MRSA infection, with 405 patients out of the 1,959 mITT patients suffering from a documented MRSA infection.