NAPSR News: FDA Approves ORBACTIV (oritavancin) for Bacterial Skin Infections

WASHINGTON - Aug. 7, 2014 - PRLog -- The U.S. Food and Drug Administration (FDA) has approved The Medicines Company’s ORBACTIV(TM) (oritavancin) an injectable antibiotic treatment for acute bacterial skin and skin structure infections (ABSSSIs) in adults. These infections are caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA). ORBACTIV is the first and only antibiotic approved by the FDA to be administered in a single, once-only treatment regimen.

“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.”

The approval was based on results obtained from the clinical studies, SOLO I and SOLO II which were randomized, double-blind, multicenter trials that assessed a single 1200 mg IV dose of ORBACTIV for the treatment of ABSSSI in 1,987 patients.

G. Ralph Corey, MD, Professor of Medicine and Infectious Diseases at Duke University stated, “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 FDA approval of ORBACTIV marks an impressive accomplishment for the Medicines Company, being the first infectious disease treatment in the company’s product pipeline to battle infections caused by resistant strains of bacteria.

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