FDA to Review Xofluza sNDA for Flu Treatment in Patients at High Risk for Complications

The Food and Drug Administration (FDA) has accepted for review the supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil; Genentech) for the treatment of influenza in patients at high risk of complications.

High risk individuals may include patients ≥65 years of age, or those with comorbid conditions (i.e., asthma, chronic lung disease, morbid obesity or heart disease). The sNDA is based on data from the phase 3 CAPSTONE-2 trial which included 2184 patients (≥12 years of age) who were at high risk for complications from the flu. Patients were randomized to receive a single dose of baloxavir marboxil at 40mg or 80mg, placebo, or oseltamivir 75mg twice daily for 5 days.

Results showed that baloxavir marboxil significantly reduced the time to improvement of influenza symptoms versus placebo (median time 73.2 hours vs 102.3 hours; P<.0001) and reduced the time to improvement of symptoms vs placebo and oseltamivir in influenza type B (median time of 74.6 hours vs 100.6 hours and 101.6 hours, respectively (P=.0138, P=.0251).

“Xofluza is the first antiviral medicine to demonstrate a significant and clinically meaningful benefit in people at high risk of complications from the flu, for which there are currently no approved medicines,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.

Xofluza, a polymerase acidic endonuclease inhibitor, was approved in October 2018 as the first single-dose oral medicine for the treatment of acute uncomplicated influenza in patients ≥12 years of age who have been symptomatic for no more than 48 hours. A Prescription Drug User Fee Act (PDUFA) target date for the sNDA has been set for November 4, 2019.

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