Xofluza is indicated to treat acute uncomplicated influenza in healthy children aged five to less than 12 years with symptoms for not over 48 hours.
The regulatory approval represents xofluza as the first single-dose oral medication approved to treat influenza for this age group children.
In addition, the medicine received FDA approval to prevent post-exposure prophylaxis of influenza in children of the same age group after coming in contact with an infected person.
Genentech Global Product Development head and chief medical officer Levi Garraway said: “Despite the ongoing Covid-19 pandemic, influenza continues to be a threat to public health, and effective influenza antivirals remain critical to alleviating the burden on healthcare systems.
“Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents, and we are pleased to now offer households and younger children our single-dose oral treatment.”
The regulatory approval is based on the data obtained from two Phase III trials, BLOCKSTONE and miniSTONE-2.
In the BLOCKSTONE trial, xofluza was evaluated as a preventive treatment vs placebo to treat influenza in household members (adults and children).
The medicine was compared with oseltamivir in healthy children aged five to less than 12 years with influenza infection and with symptoms for not more than 48 hours in the miniSTONE-2 trial.
The data from the miniSTONE-2 trial was published in The Pediatric Infectious Disease Journal and BLOCKSTONE trial in The New England Journal of Medicine.