EC approves influenza antiviral for children over one years old

The European Commission (EC) has approved Xofluza^® (baloxavir marboxil) in children aged one year and above for uncomplicated influenza and post-exposure prophylaxis of influenza.  

The European Commission’s approval

The agency’s regulatory approval, based on the results of two Phase III studies, marks the first single-dose, oral influenza medicine approved in Europe for children.

Dr Levi Garraway, PhD, Roche’s Chief Medical Officer and Head of Global Product Development explained the oral antiviral “… offers patients the first novel mechanism of action for treating influenza approved in Europe in almost 20 years.” 

Phase III studies for Xofluza^®

The miniSTONE-2 study showed that compared with oseltamivir, Xofluza^® reduced the length of time that influenza was released from the body by more than two days compared with oseltamivir (viral replication; median time of 24.2 hours versus 75.8 hours, respectively). Xofluza was well tolerated with no new safety signals identified. The Phase III study evaluated a single-dose of Xofluza^® in otherwise healthy children aged one to less than 12 years with influenza infection and displaying influenza symptoms for no more than 48 hours (temperature of 38°C or over, and one or more respiratory symptoms).

In the BLOCKSTONE study, compared with placebo, Xofluza^® reduced the risk of people developing influenza after exposure to an infected household member by 86 percent versus placebo after just a single oral dose. The proportion of households, who developed laboratory-confirmed clinical influenza was 1.9 percent in participants treated with Xofluza^® and 13.6 percent in the placebo-treated group. Xofluza^® was well tolerated in this study and no new safety signals were identified.

“We are delighted that the European Commission has approved Xofluza^® for children aged one year and above, as influenza can be particularly dangerous for younger children,” added Dr Garraway.