Genentech announces FDA approval of Xofluza (baloxavir marboxil) for influenza

SOUTH SAN FRANCISCO, Calif. — Genentech, a member of the Roche Group  announced that the U.S. Food and Drug Administration (FDA) has approved Xofluza (baloxavir marboxil) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years of age and older. Xofluza is a first-in-class, single-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication. Xofluza has demonstrated efficacy against a wide range of influenza viruses, including oseltamivir-resistant strains and avian strains (H7N9, H5N1) in non-clinical studies.

“Xofluza is the first new flu medicine with a novel proposed mechanism of action approved in nearly 20 years, and we’re excited to offer a convenient treatment option that reduces flu symptoms by more than a day with a single oral dose,” said Sandra Horning, chief medical officer and head of Global Product Development. “If patients see their doctors within 48 hours of symptom onset, one dose of Xofluza can significantly reduce the duration of flu symptoms.”

Each year, an estimated 3-11%t of the U.S. population gets the flu, and it can be very serious, resulting in hospitalization or even death. Since 2010, the Centers for Disease Control and Prevention (CDC) estimates that the flu has resulted annually in 9.2 to 35.6 million illnesses, 140,000 to 900,000 hospitalizations and 12,000 to 80,000 deaths.

“The devastation of last year’s flu season underscores the need for new treatment options beyond currently available antivirals or over-the-counter medications,” said Serese Marotta, chief operating officer, Families Fighting Flu. “While the flu vaccine is a crucial first step in preparing for flu season and preventing illness, Xofluza is an important new treatment option if you do get sick.”