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Xofluza

This page shows the latest Xofluza news and features for those working in and with pharma, biotech and healthcare.

Roche’s flu pill Xofluza gains EU approval

Roche’s flu pill Xofluza gains EU approval

Swiss pharma company Roche has scored approval from the European Commission (EC) for its flu pill Xofluza. ... Xofluza offers patients the first novel mechanism of action for treating influenza approved in Europe in almost 20 years.

Latest news

  • Roche’s Xofluza pill wins FDA approval for post-exposure flu prevention Roche’s Xofluza pill wins FDA approval for post-exposure flu prevention

    In the phase 3 BLOCKSTONE study, Xofluza achieved its primary endpoint of fewer people testing positive for flu when given as a post-exposure prophylaxis treatment. ... Xofluza was first approved by the FDA last year, and is available as a treatment for

  • Roche’s flu pill Xofluza moves closer towards EU approval Roche’s flu pill Xofluza moves closer towards EU approval

    The CHMP has recommended Xofluza (baloxavir marboxil) for approval in the EU as a treatment for uncomplicated influenza patients aged 12 years and above. ... Separately, Xofluza has been recommended for approval in the EU for post-exposure prophylaxis of

  • Roche scores another FDA approval for Xofluza Roche scores another FDA approval for Xofluza

    It demonstrated that Xofluza significantly reduced the time of improvement of flu symptoms, including in people with flu type B virus. ... However, similar efficacy results were seen between Xofluza and oseltamivir in relation to duration of symptoms

  • Roche’s flu drug Xofluza scores phase 3 primary endpoint Roche’s flu drug Xofluza scores phase 3 primary endpoint

    The trial also observed Xofluza in household members who are at high risk of flu-associated complications and children under 12 years of age. ... Xofluza was approved by the  FDA last year, and is available as a treatment for acute, uncomplicated

  • Roche’s new flu pill Xofluza approved in US Roche’s new flu pill Xofluza approved in US

    Xofluza is given as a convenient single (one time) dose compared to Tamiflu’s twice daily dosing. ... Xofluza significantly reduced the duration of flu symptoms compared to placebo, and demonstrated similar efficacy compared to oseltamivir.

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