FDA accepts Genentech’s drug applications for Xofluza in children

The FDA has accepted a new drug application and two new supplemental drug applications for the influenza antiviral Xofluza, all involving children, Genentech announced.

The new drug application is for a new formulation of Xofluza (baloxavir marboxil) — a one-dose granule (2 mg/mL) for oral suppression. This could offer children and others who have difficulty swallowing pills a more convenient option.

Genentech also is seeking approval for baloxavir marboxil to treat acute uncomplicated influenza in otherwise healthy children aged between 1 and 12 years, who have been symptomatic for no more than 48 hours, and as postexposure prophylaxis for influenza in people aged older than 1 year for both oral suspension and tablet form, which is currently available.

The FDA is expected to make its decision on these applications by Nov. 23, the company said.

“As this has been one of the hardest hitting influenza seasons for children in the past decade, there is a critical need for additional treatment options that attack influenza in different ways,” Levi Garraway, MD, PhD, chief medical officer and head of global product development at Genentech, said in a statement. “Today’s milestone brings us closer to providing single-dose Xofluza to children with influenza. We also look forward to working with the FDA to incorporate Xofluza as a preventive treatment following exposure to influenza.”

Baloxavir marboxil is approved by the FDA to treat influenza in anyone aged older than 12 years who have influenza symptoms for no more than 48 hours and who are otherwise healthy or at high risk of developing influenza-related complications.

Genentech’s filings were based on positive results from two phase 3 studies, miniSTONE-2 and BLOCKSTONE, which were recently presented as late breakers in Singapore at the 2019 OPTIONS X congress.

The miniSTONE-2 study looked at safety, pharmacokinetics and efficacy of single-dose, oral suppression baloxavir marboxil compared with oseltamivir in otherwise healthy children aged between 1 and 12 years with influenza.

BLOCKSTONE compared baloxavir marboxil with a placebo as a preventive treatment for household members who were living with someone with influenza.

Disclosure: Garraway is employed by Genentech.