CHMP positive recommendation for Xofluza (baloxavir marboxil) for infant patients in the EU for the treatment of uncomplicated influenza – Roche
The Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for Xofluza. The marketing authorisation holder is Roche Registration GmbH. The CHMP adopted an extension to the existing indication to include the treatment of patients from 3 weeks of age. The indications for Xofluza will therefore be as follows: Treatment of influenza- Xofluza is indicated for the treatment of uncomplicated influenza in patients aged 3 weeks and above.
Post‑exposure prophylaxis of influenza- Xofluza is indicated for post‑exposure prophylaxis of influenza in individuals aged 3 weeks and above.
The CHMP has endorsed an extension for Xofluza, allowing its use in patients as young as three weeks old. This decision marks a significant advancement in the management of influenza among younger demographics, potentially reducing the impact of the virus in this vulnerable age group.. This expansion ensures broader accessibility of the medication, catering to a wider age range and enhancing its utility in flu prevention and treatment strategies. Detailed recommendations for use will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official EU languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
