EMA Panel Backs Zanamivir IV for Complicated, Severe Influenza

Troy Brown, RN

March 01, 2019

The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended marketing authorization under exceptional circumstances for zanamivir (Dectova, GlaxoSmithKline Trading Services Limited) for the treatment of patients with complicated and potentially life-threatening influenza.

It is intended for intravenous use in patients too ill to use or unable to tolerate oral or inhaled treatments.

Zanamivir is a neuraminidase inhibitor that will be marketed as a 10-mg/mL solution for intravenous infusion. Neuraminidase is an enzyme that enables the influenza virus to enter uninfected cells and allows the new virus to spread in the infected individual.

Zanamivir is sold under the trade name Relenza in the United States. The US Food and Drug Administration approved it as an inhalational agent for the treatment of adults and adolescents aged 12 years or older with acute influenza A or B in 1999 and for the prevention of influenza A and B in adults and children aged 5 years or older in 2006.

Zanamivir's benefits include its ability to hasten the improvement of clinical signs and recovery in those with complicated and potentially fatal influenza. The most frequently seen adverse effects are diarrhea, elevations in levels of hepatic transaminase, hepatocellular injury, and rash.

The complete indication is for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and pediatric patients (aged ≥6 months) in the following circumstances:

  • The influenza virus infecting the patient is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or

  • Other antiviral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.

Zanamivir should be used in accordance with official guidance.

The summary of product characteristics will include detailed recommendations for use of the product and will be published in the European public assessment report, which will be made available in all official European Union languages after the European Commission grants marketing authorization.

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