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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.

Go deeper:

Go deeper

Updated 2 hours ago - Politics & Policy

Coronavirus dashboard

Illustration: Eniola Odetunde/Axios

  1. Health: Most vulnerable Americans aren't getting enough vaccine information — Fauci says Trump administration's lack of facts on COVID "very likely" cost lives.
  2. Politics: Biden unveils "wartime" COVID strategyBiden's COVID-19 bubble.
  3. Vaccine: Florida requiring proof of residency to get vaccine — CDC extends interval between vaccine doses for exceptional cases.
  4. World: Hong Kong to put tens of thousands on lockdown as cases surge.
  5. Sports: 2021 Tokyo Olympics hang in the balance.
  6. 🎧 Podcast: Carbon Health's CEO on unsticking the vaccine bottleneck.

Trump impeachment trial to start week of Feb. 8, Schumer says

Senate Majority Leader Chuck Schumer. Photo: The Washington Post via Getty

The Senate will begin former President Trump's impeachment trial the week of Feb. 8, Majority Leader Chuck Schumer announced Friday on the Senate floor.

The state of play: Schumer announced the schedule after reaching an agreement with Republicans. The House will transmit the article of impeachment against the former president late Monday.

4 hours ago - Health

CDC extends interval between COVID vaccine doses for exceptional cases

Photo: Joseph Prezioso/AFP via Getty

Patients can space out the two doses of the coronavirus vaccine by up to six weeks if it’s "not feasible" to follow the shorter recommended window, according to updated guidance from the Centers for Disease and Control and Prevention.

Driving the news: With the prospect of vaccine shortages and a low likelihood that supply will expand before April, the latest changes could provide a path to vaccinate more Americans — a top priority for President Biden.