Oct 24, 2018

FDA approves new single-dose flu treatment Xofluza

Photo of women swallowing a red and white pill

Photo: Karl Tapales/Getty Images

The Food and Drug Administration Wednesday approved Xofluza, the first novel treatment approved for the flu in almost 20 years, which targets the virus at an earlier stage in its development in the human body in the hopes of lessening recovery time.

Why it matters: Seasonal flu varies year-to-year but can be quite deadly, as seen last season when at least 80,ooo Americans were killed. Having another tool to combat the virus is "causing a lot of excitement in the public health community," says Mark Eisner, vice president of product development immunology, infectious disease and ophthalmology at Genentech, which made the drug.

The background: There was a lot of buzz when the Japanese company Shionogi announced that its drug was effective in killing off the virus in just 1 dose. It was further developed and commercialized globally with the Roche Group (including Genentech).

  • The FDA gave it priority review to expedite the approval process.
  • 2 clinical trials proved Xofluza is safe and effective, and that it facilitates a faster recovery compared to a placebo in a time roughly equal to patients taking another type of antiviral, Tamiflu (generic name oseltamivir).
  • Xofluza is now approved for acute flu patients 12 years of age and older who have been symptomatic for 48 hours or less.
  • "We're very happy FDA approved it before the flu season really started ... given how bad last year was," Eisner says.

Compared to Tamiflu, Xofluza requires 1 dose versus Tamiflu's 10 doses over 5 days.

  • Both treatments aim to halt flu replication in the human body but target different parts of its cycle. Xofluza blocks an enzyme needed for the virus to replicate earlier in the cycle and Tamiflu halts the replicated virus from leaving its host cell.
  • Both types drugs help multiple Type A and B strains of the virus.

What's next: Eisner says the drug has entered or is entering other trials to test in people younger than 12 years old, in patients hospitalized with severe flu already, whether it could prevent the transmission of flu and if it could be used as a post-exposure prophylactic.

Meanwhile, Anthony Fauci, head of the National Institute of Allergy and Infectious Disease, told Axios last week that everyone over 6 months of age should get vaccinated by the end of October.

  • So far, he said, "at this point, what we are seeing circulating around is a match to the vaccine" but even if that changes when the flu virus evolves, it will offer some protection.
  • While the Centers for Disease Control and Prevention says nationwide there is "low flu activity" as of the week ending October 14 , one child has died this 2018–2019 season.

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