FDA approves The Medicines Company's Orbactiv for use in ABSSSIs

The Food and Drug Administration has approved The Medicines Company’s (Nasdaq: MDCO) 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, the company noted. Once fully infused over three hours, the Orbactiv treatment regimen is complete for patients with skin infections caused by susceptible Gram-positive pathogens. The drugmaker expects a US launch of the product in the second half of this year.

“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, chairman and chief executive of The Medicines Company, adding: “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.”