FDA approves another antibacterial drug for skin infections
- Orbactiv (oritavancin) is an intravenous (IV) antibacterial drug for the treatment of acute bacterial skin and skin structure infections (ABSSSIs) in adults caused by susceptible, gram-positive bacteria. It is manufactured by the Medicines Company.
- Orbactiv received a priority review from the FDA and also became the third FDA-approved drug designated as a Qualified Infectious Disease Product (QIDP).
- As a QIDP, Orbactiv will have an additional five years of marketing exclusivity.
According to Edward Cox, director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research, more work is needed to develop antibacterial drugs and the FDA remains a committed partner to help promote the development of such treatments.
Towards that end, 2014 has been an excellent year. The first QIDP, Dalvance (dalbavancin) was approved for the treatment of ABSSSI on May 23. Sivextra (tedizolid) became the second FDA-approved QIDP in June 27.
The clinical trial used to support the approval of Orbactiv involved 1987 adults with ABSSSI. The drug was as effective as vancomycin. Orbactiv's approval is a breakthrough because it only requires one three-hour infusion dose to achieve the same results as seven to 10 days of treatment with vancomycin. With the ever-present threat of bacterial resistance, the continual introduction of new antibacterial and antifungal treatment options is critical.
- Pharmaceutical Business Review FDA clears third antibacterial for skin infections this year