The Medicines Company today announced that the U.S. Food and Drug Administration (FDA) has approved ORBACTIV™ (oritavancin) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
ORBACTIV is the first and only antibiotic approved by FDA to treat ABSSSIs with a single, once-only administration. Once fully infused over three hours, the ORBACTIV treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens.
“Today’s FDA approval of ORBACTIV represents an important advance beyond the current standard of care for bacterial skin and skin structure infections,” said Clive Meanwell, MD, PhD, Chairman and Chief Executive Officer of The Medicines Company. “This approval is also a significant milestone for The Medicines Company as we continue to develop our infectious disease care portfolio. We are committed to addressing the complex problems associated with multi-drug resistant infections.”
ORBACTIV approval is based on the results of the SOLO I and SOLO II clinical studies which were randomized, double-blind, multicenter trials that evaluated a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987 patients, and assessed a large subset of patients with documented MRSA infection (405 patients). These trials demonstrated non-inferiority for the primary and secondary endpoints evaluating 1200 mg once-only IV ORBACTIV dose infusion, versus 7-to-10 days of twice-daily vancomycin (1 g or 15 mg/kg).
“ORBACTIV given as a single dose treatment is a welcome new development for the treatment of skin infections,” said G. Ralph Corey, MD, Professor of Medicine and Infectious Diseases at Duke University. “With a single dose treatment regimen ORBACTIV may help reduce the dosing burden seen with antibiotics given as multiple intravenous administrations to patients with these infections.”
“The growing challenge of antibiotic resistance in the U.S. has had a significant impact on the clinical management decisions in the emergency department,” said Charles Pollack, MD, Chair, Department of Emergency Medicine, Pennsylvania Hospital and Professor of Emergency Medicine at the Perelman School of Medicine at the University of Pennsylvania. “A single, once-only IV therapy such as ORBACTIV offers the option to administer a single treatment in the outpatient setting for patients with skin infections caused by Gram-positive bacteria likely due to MRSA.”
ORBACTIV was designated as a Qualified Infectious Disease Product (QIDP) under the Generating Antibiotic Incentives Now (GAIN) Act of 2012. The QIDP designation qualifies ORBACTIV for certain incentives related to the development of new antibiotics, including a five-year extension of any non-patent exclusivity period awarded to the drug.
The European Medicines Agency has accepted for review the Marketing Authorization Application (MAA) for ORBACTIV, for which the company is seeking approval for the treatment of complicated skin and soft tissue infections (cSSTI). A decision from the European Commission is expected during the first half of 2015.
The FDA approval of ORBACTIV represents the first infectious disease treatment in The Medicines Company’s product pipeline to address infections caused by resistant strains of bacteria. The Medicines Company is developing solutions that span the spectrum of infections caused by Gram-positive bacteria including MRSA, and Gram-negative infections. The Medicines Company’s emerging product pipeline has the potential to offer innovative new antibiotic approaches to tackle many of the problems in infectious diseases today.