Third drug in three months approved under US antimicrobials incentive scheme

Intravenous antibiotic Orbactiv (oritavancin), from US firm The Medicines Company, has been approved by the US Food and Drug Administration (FDA). The drug can be used to treat acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA).

Orbactiv is the third drug to be approved (all for ABSSSIs) under the FDA’s incentive programme for encouraging companies to develop new antibiotics. It joins Durata Therapeutics’ Dalvance (dalbavancin), which was approved in May, and Cubist’s Sivextro (tedizolid), approved in June. All three were designated as Qualified Infectious Disease Products, since they combat pathogens on the FDA’s list of serious or life-threatening infections. That designation entitles the companies to speedier reviews of their regulatory applications, as well as an extra five years’ market exclusivity to take into account the restricted use of new antibiotics limiting sales.

Orbactiv and Dalvance are intravenous drugs with structures related to the current drug of last resort, vancomycin. Both are administered intravenously – Orbactiv in a single dose, compared to three infusions of Dalvance or 7–10 days of twice-daily vancomycin infusions. Sivextro is approved for both oral and intravenous use.

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