The European Commission has approved baloxavir marboxil, sold under the brand name Xofluza, for the treatment of uncomplicated influenza in patients aged 12 years and above, announced Roche.
Uncomplicated influenza illness is typically characterised by the abrupt onset of constitutional and upper respiratory tract signs and symptoms (e.g., fever, chills, myalgia, headache, malaise, nonproductive cough, sore throat, and rhinitis), while complicated illness that may include exacerbation of other underlying conditions and severe viral pneumonia with multi-organ failure.
Baloxavir marboxil is a first-in-class, single-dose, oral antiviral drug. The EC has also approved the drug for post-exposure prophylaxis of influenza in individuals aged 12 years and above. Post-exposure prophylaxis aims to prevent influenza in individuals following contact with someone infected with the influenza virus.
The approval follows the positive opinion received from the European Medicines Agency’s Committee for Medicinal Products for Human Use in November, 2020, and is based on the results of the phase III CAPSTONE-1, CAPSTONE-2 and BLOCKSTONE studies.
Globally, seasonal influenza epidemics result in three to five million cases of severe disease, millions of hospitalisations and up to 650,000 deaths every year. The WHO estimates that up to 72,000 people in the Europe region die prematurely due to causes associated with influenza each year.