New Products

Shionogi, Roche get their first approval for the next big thing in fighting the flu

Shionogi has won an approval to sell Xofluza (baloxavir marboxil) in Japan under an accelerated review pathway. And Roche plans to follow up that success by rolling it out as quickly as possible in the rest of the world.

Up to now, Tamiflu has been the chief antiviral on the market. But baloxavir could easily surpass it. The antiviral works by blocking an enzyme that the flu virus needs to replicate in a cell, and its one pill could replace the 10 required for Tamiflu over 10 days, offering any country fighting a pandemic a simpler, faster solution.

Daniel O’Day

“You don’t have the potential resistance that comes with not completing your course of therapy,” noted Roche’s Daniel O’Day in an interview with Bloomberg.

Shionogi touted a late-stage study last fall that demonstrated baloxavir’s potency, with the antiviral resolving fever after 24.5 hours, versus 42 hours for the placebo arm. That’s critical to stopping the flu from spreading rapidly. Getting back to feeling normal took 129.2 hours in the drug arm compared to 168.8 hours for the sugar pill arm.

Every year, vaccine makers line up a set of strains that they use in flu jabs, trying to anticipate which will be most virulent. This year, the vaccine missed a particularly nasty H3 strain in play, leaving millions of people vulnerable to one of the worst outbreaks in some time. Hospitalizations triggered by the flu reached a record peak earlier this month, with the old and very young most likely to be killed by the flu.

J&J, meanwhile, is working on pimodivir — in-licensed from Vertex — while another team concentrates on a universal flu vaccine, which remains one of the Holy Grails in R&D. J&J reported positive data from their mid-stage study last summer, with plans to hustle into a pivotal program of their own.

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