FDA Approves Hepatitis B Therapy for Adolescents

The FDA has approved[DM1] the supplemental new drug application (sNDA) for Gilead Sciences’ Vemlidy (tenofovir alafenamide) to treat chronic hepatitis B virus (HBV) infection in pediatric patients 12 years of age and older with compensated or asymptomatic liver disease.

Vemlidy is a targeted prodrug of tenofovir that was approved by the FDA in 2016 as a once-daily treatment for adults with chronic hepatitis B virus infection with compensated liver disease. It is recommended as a preferred or first-line treatment for adults with chronic HBV with compensated liver disease.

The average retail price for Vemlidy is $2,034.78 for 30 tablets, with the lowest retail price of $1,285.33, according to GoodRx.

Kathleen Schwarz, M.D.

“Chronic hepatitis B can have a significant long-term health impact on children, including the development of liver cancer later in life if the disease is left untreated, which is compounded by treatment challenges in this population,” investigator Kathleen Schwarz, M.D., pediatric gastroenterologist at Rady Children’s Hospital-San Diego, said in a press release.

The approval in the adolescent population is supported by 24-week data from a phase 2 clinical trial (Trial 1092) comparing treatment with Vemlidy 25 mg with placebo among 70 treatment-naïve and treatment-experienced patients. The study met its primary endpoint of percentage of patients with hepatitis B virus DNA levels below 20 IU/mL at 24 weeks of therapy; overall, 21% of patients treated with Vemlidy mg achieved this endpoint. None of the patients in the placebo arm achieved hepatitis B virus DNA levels below 20 IU/mL.