FDA Approves Single-Dose Oral Antiviral to Treat Children with Influenza

South San Francisco-based Genentech recently announced that the U.S. FDA had approved a supplemental New Drug Application (sNDA) for Xofluza® (baloxavir marboxil) for the treatment of uncomplicated acute influenza in otherwise healthy children aged five to less than 12 years of age who have been symptomatic for no more than 48 hours. 

This approval marks the first single-dose oral influenza medicine approved for children in this age group.

Additionally, the FDA approved Xofluza for the prevention (post-exposure prophylaxis) of influenza in children aged five to less than 12 years following contact with someone with flu.

Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development, stated in a press release issued on August 11, 2022, "Xofluza has proven to be an important tool in fighting and preventing influenza in adults as well as adolescents."

"And we are pleased to offer our single-dose oral treatment to households and younger children."

Xofluza is already FDA-approved for use in older children and adolescents.

It is a first-in-class, single-dose oral medicine with an innovative proposed mechanism of action that has demonstrated efficacy in a wide range of influenza viruses, including in vitro activity against oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

And is the first in a class of antivirals designed to inhibit the cap-dependent endonuclease protein, which is essential for viral replication.

This announcement is essential for the pediatric population since influenza continues to impact children negatively.

 As of August 5, 2022, the U.S. CDC reported (33) pediatric influenza-related deaths were confirmed during the 2021-2022 flu season. 

Last flu season, only (1) flu-related pediatric fatality was confirmed.

Additional flu vaccine and medication news are posted at PrecisionVaccinations.com/Flu.

Note: This Genentech announcement was manually curated for mobile readers.