ADVERTISEMENT
  • News
  • New York
  • Technology
  • Culture
  • Entertainment
  • Sport
  • More
    • Politics
    • Lifestyle
    • TV
    • Games
Tuesday, June 17, 2025
  • Login
No Result
View All Result
NEWSLETTER
FINCHANNEL
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • Americas
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • lifestyle
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • Americas
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • lifestyle
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE
No Result
View All Result
FINCHANNEL
No Result
View All Result
Home Business Pharmacy

Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Vemlidy for Patients With Chronic Hepatitis B Virus Infection

The FINANCIAL by The FINANCIAL
December 19, 2016
in Pharmacy
Reading Time: 4 mins read
8
A A
0
Japan’s Ministry of Health, Labour and Welfare Approves Gilead’s Vemlidy for Patients With Chronic Hepatitis B Virus Infection
Share on FacebookShare on Twitter

The FINANCIAL — Gilead Sciences, Inc. on December 19 announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Vemlidy (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

Vemlidy is a novel targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate (TDF) 300mg. Data show that Vemlidy has greater plasma stability and delivers tenofovir to hepatocytes more efficiently compared to TDF. As a result, Vemlidy can be given at a lower dose, reducing the concentration of tenofovir in the bloodstream. Vemlidy has also shown improvements in renal and bone laboratory safety parameters compared to TDF, according to Gilead.

“It is very exciting that a new treatment with improvements in renal and bone safety parameters is now approved for patients with chronic hepatitis B. This is an important advancement, as these patients often require lifelong therapy,” said Namiki Izumi, MD, the President of Musashino RedCross Hospital.

RelatedPosts

A Closer Look at Bioactive Peptides and Their Impact on Health

Roche ranked the most sustainable healthcare company in the DJSI

Gilead and Novo Nordisk announced new data from proof-of-concept trial in NASH

Metagenomi closes USD 65 million Series A financing led by Leaps by Bayer and Humboldt Fund

Vemlidy’s approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and treatment-experienced adult patients with HBeAg-negative and HBeAg-positive chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either Vemlidy or TDF, and Study 110 randomized and treated 873 HBeAg-positive patients with either Vemlidy or TDF. Study 108 enrolled 27 patients from 11 sites in Japan and Study 110 enrolled 46 patients from 16 sites in Japan. Both studies met their primary endpoint of non-inferiority to TDF based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.

In an integrated analysis of both studies, patients receiving Vemlidy demonstrated improvements in bone and renal laboratory parameters compared to those treated with TDF. Patients in the Vemlidy arm also experienced numerically higher rates of normalization of serum alanine aminotransferase (ALT) levels.

Vemlidy and TDF were generally well-tolerated by patients in both studies and discontinuations due to adverse events were 1% and 1.2%, respectively. In both studies, the most commonly reported adverse events included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or TDF.

“There are currently more than one million people in Japan chronically infected with hepatitis B, and we believe Vemlidy is an important option for patients living with this disease,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development, and Chief Scientific Officer. “We have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety profile of Vemlidy, and we look forward to making the medication available in Japan soon.”

Gilead is now preparing to launch Vemlidy as quickly as possible.

In Japan, TDF is sold by GlaxoSmithKline K.K.

Important Safety Information and Indication for Vemlidy in the U.S.

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs.

Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.

Warnings and Precautions

Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone is not recommended for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.

New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.

Renal monitoring: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate.

Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, fatigue, cough, nausea and back pain.

Drug Interactions

Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.

Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption.

Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

Dosage: Adults; 1 tablet taken once daily with food.

Renal Impairment: Not recommended in patients with CrCl <15 mL/min.

Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.

Testing prior to initiation: HIV infection.

Indication

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

 

Related Posts

A Closer Look at Bioactive Peptides and Their Impact on Health
Clinics

A Closer Look at Bioactive Peptides and Their Impact on Health

by Accessily
October 15, 2024
0

Introduction to Bioactive Peptides What are Bioactive Peptides? Bioactive peptides are short protein fragments, typically ranging from 2 to 20...

Read more
Roche ranked the most sustainable healthcare company in the DJSI

Roche ranked the most sustainable healthcare company in the DJSI

November 16, 2020
Gilead and Novo Nordisk announced new data from proof-of-concept trial in NASH

Gilead and Novo Nordisk announced new data from proof-of-concept trial in NASH

November 16, 2020
Metagenomi closes USD 65 million Series A financing led by Leaps by Bayer and Humboldt Fund

Metagenomi closes USD 65 million Series A financing led by Leaps by Bayer and Humboldt Fund

November 12, 2020

Discussion about this post

  • Trending
  • Comments
  • Latest
Ampersand wins £22m five-year contract at London Zoo

Ampersand wins £22m five-year contract at London Zoo

June 25, 2012
Goga Samushia, Director of Commersant

Commersant to Launch New Multimedia Finance Project

June 14, 2025
Fullscript vs. Rupa Health: What the Acquisition Means for Providers and Patients

Fullscript vs. Rupa Health: What the Acquisition Means for Providers and Patients

June 11, 2025
Will digital media be decisive in general election – as it was in Donald Trump’s victory? 

How to Align Social Media with Your Overall Marketing Strategy

June 11, 2025
Leon Botstein’s Five-Decade Transformation at Bard College

Leon Botstein’s Five-Decade Transformation at Bard College

May 28, 2025
Looking For A New Property? Here Are 10 Things You Need To Consider During The Hunt

Looking For A New Property? Here Are 10 Things You Need To Consider During The Hunt

June 16, 2025
7 Digital Marketing Techniques for Business Owners in 2020

Lockton Surprasses $4 Billion in FY2025 revenue

June 16, 2025
Protected: Why Insurance is So Important for Project Management

Protected: Why Insurance is So Important for Project Management

June 16, 2025
Mounting pressure beginning to drive progress for women in senior leadership

Women-Led Businesses Continue To Grow in 2025

June 16, 2025
Ukraine fires US-supplied longer-range missiles into Russia, Moscow says

Ukraine Support: Europe largely fills the US aid withdrawal, lead by the Nordics and the UK

June 16, 2025
ADVERTISEMENT

Popular Last 24h

  • Goga Samushia, Director of Commersant

    Commersant to Launch New Multimedia Finance Project

    59 shares
    Share 24 Tweet 15
  • Women-Led Businesses Continue To Grow in 2025

    28 shares
    Share 11 Tweet 7
  • Ampersand wins £22m five-year contract at London Zoo

    3631 shares
    Share 1452 Tweet 908
  • Ukraine Support: Europe largely fills the US aid withdrawal, lead by the Nordics and the UK

    22 shares
    Share 9 Tweet 6
  • Leon Botstein’s Five-Decade Transformation at Bard College

    314 shares
    Share 126 Tweet 79
  • New Columns and Global Partnerships on the Horizon for Publika

    23 shares
    Share 9 Tweet 6
  • Nestlé Georgia: A Leader in Baby Food Quality and Innovation

    38 shares
    Share 15 Tweet 10

LATEST POSTS

Looking For A New Property? Here Are 10 Things You Need To Consider During The Hunt

Looking For A New Property? Here Are 10 Things You Need To Consider During The Hunt

June 16, 2025
7 Digital Marketing Techniques for Business Owners in 2020

Lockton Surprasses $4 Billion in FY2025 revenue

June 16, 2025
Protected: Why Insurance is So Important for Project Management

Protected: Why Insurance is So Important for Project Management

June 16, 2025
Mounting pressure beginning to drive progress for women in senior leadership

Women-Led Businesses Continue To Grow in 2025

June 16, 2025
Ukraine fires US-supplied longer-range missiles into Russia, Moscow says

Ukraine Support: Europe largely fills the US aid withdrawal, lead by the Nordics and the UK

June 16, 2025
Supply chain management degree course among best in world

 How Apps Are Reshaping Supplier Risk and Compliance

June 15, 2025

A Tutorial on Crafting the Perfect LinkedIn Profile Along with Your Resume

June 15, 2025
Israel’s Illegal, Counterproductive Attacks Make a Nuclear-Armed Iran More Likely

Israel’s Illegal, Counterproductive Attacks Make a Nuclear-Armed Iran More Likely

June 15, 2025
REVAZ NATROSHVILI, CEO of Proservice

Proservice Launches Cloud Solutions, Expanding Infrastructure with Innovations

June 14, 2025
ROLAND ERADZE, Founder of Bona Georgia

Bona Georgia Expands with New Showroom and Innovations in Floor Care

June 14, 2025

LATESTBUSINESS

7 Digital Marketing Techniques for Business Owners in 2020

Lockton Surprasses $4 Billion in FY2025 revenue

by The FINANCIAL
June 16, 2025
0

Mounting pressure beginning to drive progress for women in senior leadership

Women-Led Businesses Continue To Grow in 2025

by The FINANCIAL
June 16, 2025
0

REVAZ NATROSHVILI, CEO of Proservice

Proservice Launches Cloud Solutions, Expanding Infrastructure with Innovations

by Golden Brand
June 14, 2025
0

ROLAND ERADZE, Founder of Bona Georgia

Bona Georgia Expands with New Showroom and Innovations in Floor Care

by Golden Brand
June 14, 2025
0

Foodmg

The Standard of Excellence in Catering: Food Management Group Wins Golden Brand Award

by Golden Brand
June 14, 2025
0

RMN02917_sante004_prevs

From France to Georgia: Président Cheese Wins the Golden Brand Award

by Golden Brand
June 14, 2025
0

TAMTA KALANDADZE, Brand Manager at BMS

Pasta Reggia Expands Its Footprint in Georgian Market with New Products

by Golden Brand
June 14, 2025
0

EKA MAGHLAPERIDZE, Head of the Marketing Department at Libo Group

Fino: A Fresh Presence in the Georgian Market

by Golden Brand
June 14, 2025
0

GET IN TOUCH

Submit guest post/Letters to the Editor:

editor (at) finchannel.com

Sales & Marketing: (+995 558) 03 03 03 Email: marketing (at) finchannel.com

Whatsup: (+995 599) 96 52 52

Georgia:

(+995 599) 96 52 52 Email: editor (@) finchannel.com

Postal address: 17 Mtskheta str. Tbilisi, Georgia 0179 The FINANCIAL

RESOURCE

  • Work at the FINANCIAL
  • ePaper
  • Advertise in The FINANCIAL
  • Access ePaper
  • Guest posts
  • Contributed articles
  • AmericanStockNews
  • Coupon Codes
  • GLOSSY MAG
American Culture Center
ACC Partner

GUIDEBOOK

  • Meet our team
  • Invest in Georgia
  • Become contributor
  • Archive

FOLLOW US

  • Facebook
  • Twitter
  • Google+
  • Youtube
No Result
View All Result
  • Home
  • Business
    • BANKS
      • GeoBanks
    • Finance
    • Insurance
    • Markets
    • Pharmacy
    • Press Releases
    • RealEstate
    • RealEstate
    • Finance
    • Insurance
    • Banks
      • GeoBanks
    • Markets
    • Press Releases
    • Personal Finance
  • World
    • Americas
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Europe
    • Georgia
      • Media
    • Ukraine
    • Americas
    • UK local news
  • Travel
    • Hotels in Georgia
    • Tours in Georgia
  • Videos
    • Promos
    • Soundslides
    • TheClinics
    • TheHoteliers
    • TheUniversities
    • TheHoteliers
    • TheClinics
    • TheUniversities
    • BestWorkplaces
    • Soundslides
    • Promos
    • Banking Forum
      • Promos
      • Soundslides
      • TheClinics
      • TheHoteliers
      • TheUniversities
  • Opinion
    • Editorial
      • Analysis
      • GORBI
      • OP-ED
      • VISA Editorial
    • Analysis
    • Gorbi
    • Book reviews
  • Tech
  • Interview
  • People
    • lifestyle
    • Health & Beauty
      • Coronavirus
    • LifeStyle
    • Employment
      • MyCareer
    • Education
    • Media
    • Celebrities
  • Oil&Auto
    • Auto
    • Energy
  • EN
    • EN
    • GE

© 2025 Intelligence Group llc

Welcome Back!

Login to your account below

Forgotten Password?

Retrieve your password

Please enter your username or email address to reset your password.

Log In

Add New Playlist

This website uses cookies. By continuing to use this website you are giving consent to cookies being used. Visit our Privacy and Cookie Policy.