• Drug Coverage
  • Hypertrophic Cardiomyopathy (HCM)
  • Vaccines: 2023 Year in Review
  • Eyecare
  • Urothelial Carcinoma
  • Women's Health
  • Hemophilia
  • Heart Failure
  • Vaccines
  • Neonatal Care
  • Type II Inflammation
  • Substance Use Disorder
  • Gene Therapy
  • Lung Cancer
  • Spinal Muscular Atrophy
  • HIV
  • Post-Acute Care
  • Liver Disease
  • Pulmonary Arterial Hypertension
  • Safety & Recalls
  • Biologics
  • Asthma
  • Atrial Fibrillation
  • Type I Diabetes
  • RSV
  • COVID-19
  • Cardiovascular Diseases
  • Breast Cancer
  • Prescription Digital Therapeutics
  • Reproductive Health
  • The Improving Patient Access Podcast
  • Blood Cancer
  • Ulcerative Colitis
  • Respiratory Conditions
  • Multiple Sclerosis
  • Digital Health
  • Population Health
  • Sleep Disorders
  • Biosimilars
  • Plaque Psoriasis
  • Leukemia and Lymphoma
  • Oncology
  • Pediatrics
  • Urology
  • Obstetrics-Gynecology & Women's Health
  • Opioids
  • Solid Tumors
  • Autoimmune Diseases
  • Dermatology
  • Diabetes
  • Mental Health

FDA Approves Vemlidy for Children with Hepatitis B


Vemlidy is now approved to treat patients 6 years and older with chronic hepatitis B virus infection.

The FDA has expanded the indication of Vemlidy (tenofovir alafenamide) for patients with chronic hepatitis B virus (HBV) infection. It now approved to treat pediatric patients 6 years of age and older and weighing at least 25 kg. Vemlidy is already available to treat adults and adolescents 12 years and older.

Hepatitis B (HBV) is a serious disease that attacks the liver and can cause chronic infection, cirrhosis of the liver, liver cancer, and death in up to a third of patients. Hepatitis B is spread through infected blood or body fluids, sexual contact, injection drug use, or perinatally from mother to child.

Chaun-Hao Lin, M.D.

Chaun-Hao Lin, M.D.

“Chronic hepatitis B can have a significant and lasting impact on the health of children. If left untreated, hepatitis B can lead to liver cirrhosis and liver cancer,” Chaun-Hao Lin, M.D., Associate Professor of Clinical Pediatrics Krek School of Medicine of USC, said in a news release.

Developed by Gilead Sciences, Vemlidy is a targeted prodrug of tenofovir that was first approved by the FDA in 2016. In 2023, Vemlidy generated total worldwide sales of $862 million compared with 842 million in 2022.

Vemlidy 25 mg has a price of $1,528 for 30 tablets, according to Drugs.com. Patients with commercial insurance may be eligible for a $0 copay with an annual limit of $6,000 a year. Gilead notes in its terms and conditions that it may reduce or discontinue the copay assistance if a patient’s plan has a copay accumulator or maximizer program.

With accumulator programs, the money from copay cards does not count toward patients’ annual deductible or out-of-pocket limit. With maximizer programs, the copay assistance is evenly spread over the year but still doesn't count toward the deductible or out-of-pocket limit.

Vemlidy’s approval in the patient population is supported by week 96 data from a phase 2 clinical trial comparing treatment with Vemlidy 25 mg with placebo among 18 treatment-naïve and treatment-experienced patients aged 6 to less than 12 years. In the trial, 47 patients received Vemlidy and 23 received placebo. Patients in the Vemlidy group and in the placebo group who switched to open-label Vemlidy after week 24 demonstrated progressive increases in the rates of virological suppression through week 96 overall.

Most common adverse events in the children were: nasopharyngitis, headache, COVID-19, pyrexia, diarrhea, upper respiratory tract infection, cough, respiratory tract infection viral, and abdominal pain.

Vemlidy has a boxed warning in its product label about the risk of new or worsening renal impairment, the risk of HIV-1 resistance, and the risk of lactic acidosis.

Related Videos
Related Content
© 2024 MJH Life Sciences

All rights reserved.