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Cubist’s superbug drug clears FDA panel

Cubist’s latest antibiotic won praise from a panel of FDA advisers, setting the stage for a likely approval and head-to-head competition with Pfizer’s blockbuster Zyvox.

The FDA’s Anti-Infective Drugs Advisory Committee voted 14-0 to recommend approval for Cubist’s tedizolid phosphate to treat acute bacterial skin infections, which are caused by drug-resistant pathogens including MRSA. The drug can be administered either orally or intravenously, and Cubist plans to market it under the brand name Sivextro.

If Cubist’s drug wins an expected approval, its commercial future will be closely tied to how it performs against Pfizer’s well-established antibiotic, which pulled in $1.4 billion last year. In Phase III trials, Cubist’s candidate proved itself non-inferior to Zyvox, and the drug boasts fewer side effects along with less frequent dosing and shorter treatment times.

That said, Zyvox is set to lose patent protection in 2015, meaning Sivextro could face a generic-flooded market early in its commercial life. Still, depending on pricing, Cubist’s drug will likely have a fighting chance against even generic Zyvox, as late-stage studies found Sivextro could be taken once a day for 6 days versus twice daily for up to two weeks for Pfizer’s drug.