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Genentech’s XOFLUZA Wins FDA Approval

Single-dose oral medicine demonstrates efficacy against a wide range of influenza viruses

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By: Kristin Brooks

Managing Editor, Contract Pharma

Genentech, a member of the Roche Group, received approval from the FDA for XOFLUZA (baloxavir marboxil) for the treatment of acute flu in people 12 years of age and older. XOFLUZA is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. XOFLUZA has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, ...

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