About My Health Careers Internship MedBlogs Contact us

FDA Expands the Approval Indication for Influenza Treatment to Post- Exposure Prevention

by Aishwarya Nair on November 28, 2020 at 3:54 PM
Font : A-A+

FDA Expands the Approval Indication for Influenza Treatment to Post- Exposure Prevention

The U.S. Food and Drug Administration (US FDA) expanded the approved indication for baloxavir marboxil on 23rd Nov'20. FDA included post exposure prevention of influenza (flu) for patients 12 years of age and older after a contact with an individual suffering from flu as an expanded indication. Baloxavir marboxil was previously available only as a tablet, but now it is also available as granules for mixing in water.

Baloxavir marboxil was approved in 2018 for treating uncomplicated flu in patients of 12 years and above who have been symptomatic for not more than 48 hours.


Flu is a contagious respiratory illness caused by the influenza viruses. If the influenza patients are started on antiviral drugs within 48 hours of becoming sick, it can reduce symptoms and duration of illness. Taking an annual seasonal flu vaccine is the best way to protect against flu.

Debra Birnkrant, M.D., director of the Division of Antiviral Products in the FDA's Center for Drug Evaluation and Research said, "This expanded indication for Xofluza (Baloxavir marboxil) will provide an important option to help prevent influenza just in time for a flu season that is anticipated to be unlike any other because it will coincide with the coronavirus pandemic. Americans will have to be more vigilant than ever as these viruses spread concurrently."

The efficacy of Baloxavir marboxil was studied through a randomized, double- blind, controlled trial which consisted of 607 participants. The participants were above 12 years of age and were exposed to a person with influenza in their household.

The patients received either a single dose of baloxavir marboxil or a single dose of placebo (no drug). Out of the 607 subjects, 303 received baloxavir marboxil and 304 received the placebo. The trial's endpoint was the proportion of subjects who were infected with influenza virus and presented with fever and at least one respiratory symptom from day 1 to day 10. Only 1 % of participants who received the drug met these criteria compared to 13 % patients in the placebo.

The most common side effects of baloxavir marboxil are diarrhoea, bronchitis, nausea, sinusitis and headache.

Hypersensitivity ( undesirable effects/ allergies) can occur in patients taking Baloxavir marboxil . Patient who have experienced a hypersensitivity to baloxavir marboxil should not consume this medicine. The medicine should not be co-administered with dairy products, calcium rich beverages and food items, antacids, laxatives or any oral supplements containing calcium, iron, magnesium, selenium, aluminium or zinc.

Source: Medindia

News A-Z
News Category
What's New on Medindia
Black Pepper as Preventive Measure Against Omicron
FODMAP Diet: A Beginner's Guide
View all

Medindia Newsletters Subscribe to our Free Newsletters!
Terms & Conditions and Privacy Policy.

More News on:
Hib Vaccine Flu Swine Flu Reye’s Syndrome Preventing Flu: Good Health Habits Can Help Stop Germs Ways to Boost Your Immune System during Cold and Flu Season Neck Cracking 

Recommended Reading
FDA Approves the First Drug to Treat an Rare Genetic Disorder Which Causes Kidney Stones
FDA has approved lumasiran subcutaneous injection to treat adults and children with primary ......
FDA Authorizes Monoclonal Antibodies for COVID-19 Treatment
US FDA issued an emergency use authorization for casirivimab and imdevimab for treatment of mild to ...
Baricitinib: New Drug Effective Against Cytokine Storm In COVID-19
Baricitinib shows promise against cytokine storm in COVID 19. Baricitinib along with an antiviral .....
Tocilizumab & Sarilumab Have Limited Role in COVID-19 Treatment
Recent NIH guidelines suggest tocilizumab has a very limited role in the treatment of COVID-19....
Hib Vaccine
The Hib vaccine protects children against infections like meningitis and pneumonia that are caused b...
Neck Cracking
Neck cracking or neck popping is caused by quick movements to loosen the ligaments and joints of the...
Preventing Flu: Good Health Habits Can Help Stop Germs
How is the flu spread and how effective is flu treatment? Learn more about the influenza virus and g...
Reye’s Syndrome
Reye's syndrome is a medical emergency chiefly affecting children and teenagers and is marked by the...
Swine Flu
Swine flu, a type of influenza caused by a new strain of the H1N1 Type A influenza virus has origina...
Ways to Boost Your Immune System during Cold and Flu Season
Your immune system has to be strong to fight the bacteria and viruses that enter the body and cause ...

Disclaimer - All information and content on this site are for information and educational purposes only. The information should not be used for either diagnosis or treatment or both for any health related problem or disease. Always seek the advice of a qualified physician for medical diagnosis and treatment. Full Disclaimer

© All Rights Reserved 1997 - 2022

This site uses cookies to deliver our services. By using our site, you acknowledge that you have read and understand our Cookie Policy, Privacy Policy, and our Terms of Use