Genentech Files NDA for Flu Drug

FDA has accepted for priority review a Genentech NDA for baloxavir marboxil, a single-dose, oral treatment for acute, uncomplicated influenza in people 12 years and older. The agency set a user fee review action target of 12/24. “Baloxavir marboxil has been shown in clinical trials to decrease the duration of symptoms with one dose, and demonstrated a significant reduction in viral shedding in just one day,” the company says. Unlike other currently available antiviral treatments, baloxavir marboxil is designed to inhibit the cap-dependent endonuclease protein within the flu virus, which is essential for viral replication, it adds.

The NDA is based on data from the Phase 3 CAPSTONE-1 study of a single dose of baloxavir marboxil compared with placebo or oseltamivir 75 mg, twice daily for five days, in healthy people with the flu. Additionally, results from a placebo-controlled Phase 2 study are included as supporting data in the submission.