Roche seeks to expand label for Xofluza in the USA

6 March 2019

Switzerland’s Roche (ROG: SIX) has filed to expand the label for Xofluza (baloxavir marboxil) in the USA.

The US regulator will consider an application for approval to market the oral therapy as a single-dose treatment for people at high risk of complications from the flu. A decision is expected by November 4, 2019.

Roche’s subsidiary Genentech secured US approval for Xofluza in 2018, following one of the worst flu seasons in many years. The approval currently covers acute, uncomplicated flu for certain people over 12 years of age.

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