FDA’s approval of generic baloxavir marboxil tablets for influenza broads access to a novel-mechanism antiviral for individuals aged five years and over.
The US Food and Drug Administration (FDA) has approved the first generic, single-dose oral formulation of Xofluza (baloxavir marboxil) tablets for influenza in individuals aged five years and over.
This new authorisation, granted to Norwich Pharmaceuticals, Alvogen’s manufacturing and research hub, represents an advancement in treatment and prophylaxis of acute uncomplicated influenza. Xofluza is a registered trademark of Genentech.
Dr Iilun Murphy, Director of the Office of Generic Drugs within FDA’s Center for Drug Evaluation and Research, said that it “marks a meaningful milestone for the treatment of influenza. Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the US each year.”
Expanding patient access to drugs and improving their ease of use are critical public health imperatives, particularly given that influenza alone accounts for millions of illnesses in the US each year”
Dr Iilun Murphy, Director of the Office of Generic Drugs within FDA’s Center for Drug Evaluation and Research
The FDA’s decision about baloxavir marboxil reflects President Trump’s commitment to boost availability of generic drugs in the US. The administration’s decision earlier this year to impose a 100 percent tariff on imported pharmaceuticals, which does not include generics, biosimilars, and associated ingredients in the tariff rate, “will help enhance the generic medicines supply chain”, according to John Murphy III, President and CEO of the Association for Accessible Medicines (AAM).
Xofluza first gained regulatory approval in 2023. This authorisation represented the first novel mechanism of action for an influenza antiviral to be approved by the European Commission in almost two decades.
Meanwhile, this year the industry has made positive progress in broadening access to more influenza treatments. In March, the CHMP gave a positive opinion to Moderna’s mRNA COVID-19/flu vaccine mCombriax for adults aged 50 years old and over. It would be the first flu plus COVID combination vaccine if approved. Additionally, last December, CSL opened a $1 billion vaccine and antivenom manufacturing facility in Australia, which is set support production of cell-based influenza vaccines.
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