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The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for baloxavir marboxil (Xofluza®; Genentech) for the treatment of acute uncomplicated influenza in otherwise healthy children aged 1 to <12 years who have been symptomatic for ≤48 hours.
The sNDA submission is based on data from the miniSTONE-2 trial that evaluated the safety, pharmacokinetics and efficacy of baloxavir marboxil vs oseltamivir in otherwise healthy children with a confirmed influenza infection (N=176). Results showed that baloxavir marboxil was comparable to oseltamivir in reducing the duration of influenza symptoms, including fever. In addition, treatment with baloxavir marboxil, which was administered as an oral suspension, was found to be well tolerated.
Based on these findings, the Company is also seeking approval of a new formulation of baloxavir marboxil as granules for oral suspension (2mg/mL) for the treatment of pediatric patients or those with difficulty swallowing.
Additionally, the FDA has accepted for review an sNDA for the use of baloxavir marboxil as postexposure prophylaxis of influenza in patients ≥1 year. The sNDA includes data from the phase 3 BLOCKSTONE study in which participants who were living with someone with an influenza infection were randomized to receive either a single dose of baloxavir marboxil or placebo as a preventive measure. Results showed that the proportion of participants who became symptomatically ill following infection with influenza was significantly lower in the baloxavir marboxil group compared with the placebo group (1.9% vs 13.6%, P <.0001).
A Prescription Drug User Fee Act (PDUFA) date of November 23, 2020 has been designated for all of these applications.
Xofluza, a polymerase acidic endonuclease inhibitor, is currently indicated for the treatment of acute uncomplicated influenza in patients ≥12 years of age who have been symptomatic for ≤48 hours and who are otherwise healthy, or at high risk of developing influenza-related complications. It is available in 20mg and 40mg tablets.
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