FDA Approves Baloxavir Marboxil for People at High Risk of Developing Influenza-Related Complications

By Alexa Josaphouitch, /alert Contributor
Save to PDF By

The FDA recently approved baloxavir marboxil (Xofluza) for the treatment of acute, uncomplicated influenza, or flu, in people 12 years and older who have been symptomatic for no more than 48 hours and who are at high risk of developing flu-related complications. 

“With the flu season rapidly approaching, we can now offer [baloxavir marboxil] 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 at Genentech. “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.”


White tablets. Source: Getty

Baloxavir marboxil was first approved by the FDA in October 2018 for the treatment of acute, uncomplicated flu in otherwise healthy people 12 years and older who have been symptomatic for no more than 48 hours. The expanded indication is based on data from the Phase III CAPSTONE-2 study. The multicenter, randomized, double-blind study compared a single dose of baloxavir marboxil to oseltamivir and placebo in people 12 years or older who met CDC criteria for being at high risk of complications from the flu.

The time to improvement of flu symptoms was significantly reduced versus the placebo (median time 73 hours versus 102 hours; p<0.001). Similar efficacy results were seen between baloxavir marboxil and oseltamivir in relation to duration of symptoms (median time 73 hours versus 81 hours) as well as in patients with type B virus (75 hours versus 101 hours in the placebo group) .

Adverse events were reported in at least 1% of adult and adolescent subjects. This included diarrhea (3%), bronchitis (3%), nausea (2%), sinusitis (2%), and headache (1%). Overall, baloxavir marboxil was well-tolerated and no new safety signals were identified.

Baloxavir marboxil is approved in several countries for treatment of flu types A and B. It’s a one-dose oral medicine with a novel proposed mechanism of action that inhibits polymerase acidic endonuclease, an enzyme essential for viral replication.

 

© 2024 /alert® unless otherwise noted. All rights reserved.
Reproduction in whole or in part without permission is prohibited.
Privacy Policy | Terms of Use | Editorial Policy | Advertising Policy