The Medicines Company announced that the European Medicines Agency (EMA) has accepted for review its marketing authorization application (MAA) for Oritavancin, its investigational antibiotic for treatment of complicated skin and tissue infections (cSSTI), also known as acute bacterial skin and skin structure infections (ABSSSIs).
The MAA for oritavancin is based on results from two Phase III clinical trials SOLO I and SOLO II. The late stage trials assessed the safety and efficacy of a single 1,200 mg dose of oritavancin against 7 to 10 days administration of twice-daily vancomycin in adults with cSSTI including infections caused by MRSA. The two SOLO studies involved 1,959 patients (modified intent-to-treat population or mITT), with 405 experiencing cSSTI with a history of methicillin-resistant staphylococcus aureus (MRSA) infection.
SOLO I and SOLO II studies combined represent the largest patient population ever to be assessed for an anti-infective for cSSTI in controlled clinical trials. The combined trials also evaluated one of the largest subsets of patients with documented MRSA infection.
Oritavancin is an investigational intravenous antibiotic intended for the treatment of cSSTI caused by susceptible gram-positive bacteria including MRSA. The drug is administered in a single dose, in contrast to other antibiotic therapy regimens.
The drug has already been granted Qualified Infectious Disease Product (QIPD) status by the FDA last year for eligibility for fast track status. If approved, oritavancin will gain five years of exclusivity for the treatment of acute bacterial skin and skin structure infections. The QIPD status was given under the Generating Antibiotic Incentives Now (GAIN) Act, included in the FDA Safety and Innovation Act (FDASIA).
The company said it looks forward to the beginning of the review process of oritavancin in the EU as marked by its acceptance. The Medicines Company focuses on 3,000 leading acute/intensive care hospitals around the world and provides solution in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care.