Vemlidy is indicated to treat chronic HBV infection in paediatric patients. Credit: Nephron / commons.wikimedia.org.

The US Food and Drug Administration (FDA) has  approval for the supplemental new drug application (sNDA) of 鈥� Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in paediatric patients.

This approval has been granted for once-a-day 25mg tablets of Vemlidy for usage in paediatric patients aged 12 years and above with compensated liver disease.

Go deeper with GlobalData

  • ReportsLogo

  • ReportsLogo

Data Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

The latest approval is backed by 24-week findings from a Phase II clinical trial (Trial 1092) that analysed 25mg Vemlidy versus placebo in 70 paediatric patients who are treatment-na茂ve and treatment-experienced. 

Trial 1092 met the primary endpoint of the percentage of subjects with HBV deoxyribonucleic acid (DNA) levels less than 20 IU/ml following 24 weeks of treatment.

At 24 weeks, 21% of the participants who received 25mg Vemlidy attained HBV DNA less than 20IU/ml versus 0% in the placebo arm.

A targeted tenofovir prodrug, Vemlidy had priorly received FDA approval in 2016 as a once-a-day treatment in adults for chronic HBV infection with compensated liver disease. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile 鈥� free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

chief medical officer Merdad Parsey said: 鈥淲hile paediatric hepatitis B prevalence has dropped significantly in the US, children who develop chronic hepatitis B following an acute infection can experience lifelong health impact. 

鈥淕ilead is focused on meeting the biggest challenges in liver disease and impacting the course of the disease. With an established safety profile and once-daily dosing, Vemlidy provides physicians with a new option to address the treatment needs of paediatric patients living with hepatitis B.鈥�

In October this year, the company entered an exclusive option and partnership agreement with MacroGenics to develop bispecific antibodies.