FDA approves flu medicine Xofluza for youthful kids

August 12, 2022

2 min learn

Garraway works for Genentech. Healio couldn’t verify related monetary disclosures for Piedra on the time of publication.

The FDA has permitted the oral influenza medicine Xofluza for kids aged 5 to 11 years who’ve been symptomatic for not more than 48 hours, Genentech introduced.

The company additionally permitted Xofluza as post-exposure prophylaxis (PEP) for kids in that age group who’ve had contact with somebody with influenza.

Pill bottle knocked over, other pill bottles nearby
The FDA has permitted the pediatric influenza therapy Xofluza for kids aged between 5 and fewer than 12 years. Supply: Adobe Inventory

The approvals got here 4 years after the FDA originally green-lighted Xofluza in 2018 to deal with acute uncomplicated influenza in sufferers aged 12 years or older — the primary new influenza therapy in virtually 20 years. In 2019, the FDA approved an expanded indication for sufferers aged 12 years or older who’re at excessive threat for influenza-related issues.

The medicine was discovered to be well tolerated in patients aged 1 to 11 years throughout the miniSTONE-2 research, which additionally confirmed that it diminished the danger for influenza for household contacts by 86%.

The FDA formally accepted Genentech’s application for youthful kids in March 2020, with a call anticipated by November of that yr. Nonetheless, the FDA declined to increase the provision to the youthful age group, announcing instead on Nov. 23, 2020, that it had expanded its permitted of the therapy as PEP to incorporate kids aged 12 years or older.

“Regardless of the continued COVID-19 pandemic, influenza continues to be a risk to public well being, and efficient influenza antivirals stay vital to assuaging the burden on well being care techniques,” Levi Garraway, MD, PhD, Genentech’s chief medical officer and head of world product improvement, stated in a press launch.

“Xofluza has confirmed to be an vital device in preventing and stopping influenza in adults in addition to adolescents, and we’re happy to now provide households and youthful kids our single-dose oral therapy,” Garraway stated.

Within the miniSTONE-2 research, researchers in contrast Xofluza with oseltamivir in in any other case wholesome kids, additionally together with sufferers aged 5 to 11 years with an influenza an infection who had signs for not more than 48 hours. Reported hostile occasions included vomiting and diarrhea.

“Traditionally, school-aged kids have performed a major function in the neighborhood transmission of influenza,” Healio Pediatrics Editorial Board Member Pedro A. Piedra, MD, miniSTONE-2 research investigator and a professor at Baylor Faculty of Medication, stated within the launch. “The annual influenza vaccine continues to be crucial first step to forestall sickness in kids, although there can nonetheless be breakthrough circumstances the place antiviral therapy is required.”


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