FDA approves Orbactiv to treat skin infections

Third new antibacterial drug approved for this use this year

For Immediate Release

August 6, 2014

Release

The U.S. Food and Drug Administration today approved Orbactiv (oritavancin), a new antibacterial drug to treat adults with skin infections.

Orbactiv is approved to treat patients with acute bacterial skin and skin structure infections (ABSSSI) caused by certain susceptible bacteria, includingStaphylococcus aureus (including methicillin-susceptible and methicillin-resistant strains), various Streptococcus species and Enterococcus faecalis. Orbactiv is administered intravenously.

Orbactiv is the third new antibacterial drug approved by the FDA this year to treat ABSSSI. The agency approved Dalvance (dalbavancin) in May 2014 and Sivextro (tedizolid) in June 2014.

“The approval of several new antibacterial drugs this year demonstrates that we are making progress in increasing the availability of treatment options for patients and physicians,” said Edward Cox, M.D., M.P.H, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research. “However, more work is needed in this area, and the FDA remains a committed partner to help promote the development of antibacterial drugs.”

Orbactiv is also the third new drug designated as a Qualified Infectious Disease Product (QIDP) to receive FDA approval. Under the Generating Antibiotic Incentives Now (GAIN) title of the FDA Safety and Innovation Act, Orbactiv was granted QIDP designation because it is an antibacterial or antifungal human drug intended to treat a serious or life-threatening infection.

As part of its QIDP designation, Orbactiv was given priority review, which provides an expedited review of the drug’s application. Orbactiv’s QIDP designation also qualifies it for an additional five years of marketing exclusivity to be added to certain exclusivity periods already provided by the Food, Drug, and Cosmetic Act.

Orbactiv’s safety and efficacy were evaluated in two clinical trials with a total of 1,987 adults with ABSSSI. Participants were randomly assigned to receive Orbactiv or vancomycin. Results showed Orbactiv was as effective as vancomycin for the treatment of ABSSSI.

The most common side effects identified in the clinical trials were headache, nausea, vomiting, the formation of skin and soft tissue abscesses on arms and legs and diarrhea. Orbactiv’s label also includes a warning regarding interference with coagulation tests and interaction with warfarin, a drug used to prevent blood clots.

Orbactiv is marketed by The Medicines Company, based in Parsippany, N.J.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.