The Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for Xofluza (baloxavir marboxil; Genentech) for the treatment of acute, uncomplicated influenza in patients aged 12 years and older at high risk of influenza-related complications who have been symptomatic for no more than 48 hours. High risk individuals may include patients ≥65 years of age, or those with comorbid conditions (ie, asthma, chronic lung disease, morbid obesity or heart disease).
The approval was based on data from the phase 3, multicenter, double-blind, CAPSTONE-2 study that evaluated the efficacy of a single-dose of baloxavir marboxil compared with placebo and oseltamivir in patients 12 years and older who are at a high risk of complications from the flu. Patients were randomized to receive a single dose of baloxavir marboxil 40mg or 80mg, placebo, or oseltamivir 75mg twice a day for 5 days. The primary end point was the time to improvement of influenza symptoms compared with placebo.
Findings from the study showed that baloxavir marboxil significantly reduced the time to improvement of influenza symptoms compared with placebo (median time 73 hours vs 102 hours, respectively; P <.001); the baloxavir marboxil group also had a shorter time to improvement of symptoms in patients infected with type B virus compared with the placebo group (75 hours vs 101 hours, respectively).
When compared with oseltamivir, there was no statistically significant difference in the median time to improvement of influenza symptoms (73 hours with Xofluza vs 81 hours with oseltamivir).
Xofluza, a first-in-class polymerase acidic endonuclease inhibitor, was previously approved for the treatment of acute, uncomplicated influenza in otherwise healthy patients aged 12 years and older. The Company is currently evaluating the efficacy and safety of Xofluza in several phase 3 programs, including in children under the age of 1 (NCT03653364), severely ill, hospitalized patients with the flu (NCT03684044), and in reducing transmission of the flu from an infected person to healthy people (NCT03969212).
“With the flu season rapidly approaching, we can now offer Xofluza as the first and only FDA-approved treatment option indicated specifically for those at high risk of flu complications,” said Levi Garraway, MD, PhD, chief medical officer and head of Global Product Development. “People with chronic conditions such as asthma, heart disease and diabetes are at higher risk of developing serious complications from the flu, so it is critical that these patients speak with their healthcare providers about possible treatment at the first signs and symptoms of the disease.”
Xofluza is supplied as 20mg and 40mg strength tablets in 2-count blister cards.
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