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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, H5N1) in non-clinical studies.

Each year, an estimated 3-11 percent of the U.S. population gets the flu. Since 2010, the CDC estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths. 
  
XOFLUZA was approved based on results from the Phase III CAPSTONE-1 study of a single dose of compared with placebo or oseltamivir 75 mg. XOFLUZA significantly reduced the duration of flu symptoms compared to placebo, and demonstrated similar efficacy compared to oseltamivir. In clinical trials, XOFLUZA was safe and well-tolerated with a side effect profile similar to placebo.
 
XOFLUZA will be available across the U.S. in the coming weeks.

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