FDA approves flu medication Xofluza for younger children

The FDA has approved the oral influenza medication Xofluza for children aged 5 to 11 years who have been symptomatic for no more than 48 hours, Genentech announced.

The agency also approved Xofluza as post-exposure prophylaxis (PEP) for children in that age group who have had contact with someone with influenza.

The approvals came 4 years after the FDA originally green-lighted Xofluza in 2018 to treat acute uncomplicated influenza in patients aged 12 years or older — the first new influenza treatment in almost 20 years. In 2019, the FDA approved an expanded indication for patients aged 12 years or older who are at high risk for influenza-related complications.

The medication was found to be well tolerated in patients aged 1 to 11 years during the miniSTONE-2 study, which also showed that it reduced the risk for influenza for household contacts by 86%.

The FDA formally accepted Genentech’s application for younger children in March 2020, with a decision expected by November of that year. However, the FDA declined to expand the availability to the younger age group, announcing instead on Nov. 23, 2020, that it had expanded its approved of the treatment as PEP to include children aged 12 years or older.

“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 health care systems,” Levi Garraway, MD, PhD, Genentech's chief medical officer and head of global product development, said in a press release.

“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,” Garraway said.

In the miniSTONE-2 study, researchers compared Xofluza with oseltamivir in otherwise healthy children, also including patients aged 5 to 11 years with an influenza infection who had symptoms for no more than 48 hours. Reported adverse events included vomiting and diarrhea.

“Historically, school-aged children have played a significant role in the community transmission of influenza,” Healio Pediatrics Editorial Board Member Pedro A. Piedra, MD, miniSTONE-2 study investigator and a professor at Baylor College of Medicine, said in the release. “The annual influenza vaccine continues to be the most important first step to prevent illness in children, though there can still be breakthrough cases where antiviral treatment is needed.”