The US Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for The Medicines Company's oritavancin, an investigational intravenous antibiotic, with priority review. The Medicines Company is seeking approval of oritavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.
In December 2013, the US FDA designated oritavancin as a qualified infectious disease product (QIDP). The QIDP designation provides oritavancin priority review, and an additional five years of exclusivity upon approval of the product for the treatment of ABSSSI. Priority review means the FDA's goal is to take action on the application within six months, compared to 10 months under standard review. The US FDA action date (PDUFA date) for oritavancin is August 6, 2014.
"We look forward to working with the US FDA during the review process, and sharing the knowledge we have gained in our studies of oritavancin," said Matthew Wikler, vice president and medical director, Infectious Disease Care for The Medicines Company. "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 oritavancin NDA is based on data from two phase III clinical trials, SOLO I and SOLO II, which were conducted under a Special Protocol Assessment (SPA) agreement with the FDA. These phase III trials evaluated the efficacy and safety of a single 1200mg dose of oritavancin compared to seven to 10 days of twice-daily vancomycin in adults with ABSSSI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients (modified intent-to -treat population, or mITT), with 405 of the patients suffering from an ABSSSI with a documented MRSA infection.
The Medicines Company's purpose is to save lives, alleviate suffering, and contribute to the economics of healthcare by focusing on 3,000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infectious disease care.