MedPath

Baloxavir marboxil

Generic Name
Baloxavir marboxil
Brand Names
Xofluza
Drug Type
Small Molecule
Chemical Formula
C27H23F2N3O7S
CAS Number
1985606-14-1
Unique Ingredient Identifier
505CXM6OHG

Overview

Baloxavir marboxil is an antiviral drug used to treat influenza. More specifically, it is a first-in-class cap-dependent endonuclease inhibitor that works to block influenza virus proliferation. It is a prodrug of baloxavir with an improved absorption profile than its active metabolite due to the addition of a phenolic hydroxyl group to its structure. Baloxavir marboxil was first globally approved in Japan in February 2018, followed by the US approval in October, 2018. It was also approved by the European Commission on January 7, 2021.

Background

Baloxavir marboxil is an antiviral drug used to treat influenza. More specifically, it is a first-in-class cap-dependent endonuclease inhibitor that works to block influenza virus proliferation. It is a prodrug of baloxavir with an improved absorption profile than its active metabolite due to the addition of a phenolic hydroxyl group to its structure. Baloxavir marboxil was first globally approved in Japan in February 2018, followed by the US approval in October, 2018. It was also approved by the European Commission on January 7, 2021.

Indication

Baloxavir marboxil is an influenza virus polymerase acidic (PA) endonuclease inhibitor indicated for the treatment of acute uncomplicated influenza in patients who have been symptomatic for no more than 48 hours and who are otherwise healthy adults and pediatric patients five years of age and older, or patients 12 years of age and older who are at high risk of developing influenza-related complications. The drug is also indicated for post-exposure prophylaxis of influenza in patients five years of age and older following contact with an individual who has influenza. In Europe, it is approved for use in patients aged one year and above for these indications. Baloxavir marboxil is associated with a risk for loss of efficacy due to changes in influenza virus such as changes in virus subtypes, emergence of virus resistance, and changes in viral virulence; therefore, the drug should be used after considering available information on drug susceptibility patterns for circulating influenza virus strains.

Associated Conditions

  • Flu caused by Influenza
  • Acute, uncomplicated Influenza

FDA Approved Products

Xofluza
Manufacturer:Genentech, Inc.
Route:ORAL
Strength:40 mg in 20 mL
Approved: 2024/03/11
NDC:50242-583
Xofluza
Manufacturer:Genentech, Inc.
Route:ORAL
Strength:80 mg in 1 1
Approved: 2024/03/11
NDC:50242-877
Xofluza
Manufacturer:Genentech, Inc.
Route:ORAL
Strength:40 mg in 1 1
Approved: 2024/03/11
NDC:50242-860
Xofluza
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:40 mg in 1 1
Approved: 2020/06/16
NDC:50090-4104
Xofluza
Manufacturer:A-S Medication Solutions
Route:ORAL
Strength:20 mg in 1 1
Approved: 2020/06/16
NDC:50090-4102

Singapore Approved Products

XOFLUZA FILM COATED TABLETS 40MG
Manufacturer:Shionogi Pharma Co. Ltd. (Settsu Plant), Sharp Packaging Services, LLC (Primary and Secondary Packager), F. Hoffmann-La Roche Ltd (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:40mg
Online:Yes
Approved: 2019/05/03
Approval:SIN15680P
XOFLUZA FILM COATED TABLETS 20MG
Manufacturer:Shionogi Pharma Co. Ltd. (Settsu Plant), Sharp Packaging Services, LLC (Primary and Secondary Packager)
Form:TABLET, FILM COATED
Strength:20mg
Online:Yes
Approved: 2019/05/03
Approval:SIN15679P

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