The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use recommended approval at its February meeting of the neuraminidase inhibitor (NAI) peramivir (Alpivab, Biocryst UK Ltd) for treatment of uncomplicated influenza in adults and children aged 2 years and older.
Alpivab will be available as concentrate for solution for infusion (200 mg).
"The benefits with Alpivab are its ability to speed alleviation of symptoms and recovery of normal temperature in patients with uncomplicated influenza. The most common side effects are gastrointestinal disorders, such as diarrhea and vomiting," the EMA said in a statement.
Detailed recommendations for the use of peramivir will be described in the summary of product characteristics, which will be published in the European public assessment report and will be made available in all official EU languages after the European Commission grants marketing authorization.
In the United States, peramivir is sold as Rapivab. It is one of three NAIs approved by the US Food and Drug Administration (FDA) and recommended for the 2017-2018 flu season for treatment of acute uncomplicated influenza in patients aged 2 years and older who have been symptomatic for no more than 2 days. The other two FDA-approved NAIs are oseltamivir (Tamiflu, Genentech) and zanamivir (Relenza, GlaxoSmithKline).
Late last week, as reported by Medscape Medical News, Japan's health ministry approved baloxavir marboxil tablets (Xofluza, Shionogi & Co Ltd), a novel cap-dependent endonuclease inhibitor that reportedly can kill influenza types A and B in as little as 1 day in some patients. However, the drug will not be up for approval in the United States before 2019, the Wall Street Journal reported.
The United States is in the midst of what is shaping up to be a historically severe flu season. The latest figures from the Centers for Disease Control and Prevention hint that the flu season may have peaked, but infection rates remain elevated, and overall flu activity remains high across much of the United States, the agency said.
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Cite this: EU Panel Backs Antiviral Peramivir for Uncomplicated Flu - Medscape - Feb 27, 2018.
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