7 March 2019 - - The US Food and Drug Administration has accepted a supplemental New Drug Application for Xofluza (baloxavir marboxil) as a single-dose, oral treatment for people at high risk of complications from the flu, US-based Genentech said.

Genentech is a member of the Roche Group (SIX: RO) (OTCQX: RHHBY).

The Centers for Disease Control and Prevention defines people at high risk for serious flu complications to include adults 65 years of age or older, or those who have conditions such as asthma, chronic lung disease, morbid obesity or heart disease.

The FDA is expected to make a decision on approval by November 4, 2019.

The sNDA is based on results from the Phase III CAPSTONE-2 study of a single dose of XOFLUZA compared with placebo or oseltamivir 75 mg, twice daily for five days, in people 12 years of age or older who are at high risk of complications from the flu.

The FDA approved Xofluza in October 2018 for the treatment of acute, uncomplicated influenza in people 12 years of age or older.

It is the first and only single-dose oral medicine approved to treat the flu, and the first new flu medicine with a novel proposed mechanism of action in nearly 20 years.

CAPSTONE-2 is a Phase III multicenter, randomized, double-blind study that evaluated the efficacy and safety of a single dose of Xofluza compared with placebo and oseltamivir in 2,184 people 12 years of age or older who are at high risk of complications from the flu.

The primary objective of the study evaluated the efficacy of a single dose of Xofluza compared with placebo by measuring the time to improvement of influenza symptoms.

Important secondary endpoints compared outcomes in Xofluza versus placebo or oseltamivir, including time to resolution of fever, time to cessation of viral shedding, infectious virus detection in swabs of the nose and throat, prescription of antibiotics and influenza-related complications.