Amid Gilead Science’s oncology push, the company hasn’t forgotten about its hepatitis portfolio. The latest evidence? Gilead's chronic hepatitis B virus (HBV) drug Vemlidy scored a new indication to treat pediatric patients with compensated liver disease.
Wednesday, the FDA approved the drug for patients 12 and older. It previously won approval back in 2016 for adults with chronic HBV, taking the torch from an older Gilead hep B treatment, Viread.
The FDA approved Vemlidy's new pediatric indication based on 24-week data from a Phase 2 clinical trial that pitted the therapy against placebo in 70 treatment-naïve and treatment-experienced patients ages 12 to under 18. Overall, 21% of patients achieved reduced DNA levels of HBV, compared with 0% of patients on placebo.
Chronic HBV can have “significant long-term impacts” on children, including the development of liver cancer later in life if the disease is untreated, Kathleen Schwarz, a pediatric gastroenterologist at Rady Children’s Hospital of San Diego and an investigator in the clinical trial, said in a statement.
While the prevalence of the disease has “dropped significantly” in the U.S., Gilead is still “focused on meeting the biggest challenges in liver disease” and changing the course of the disease, Merdad Parsey, Chief Medical Officer at Gilead, said in a company statement.
When the drug won its first approval to treat adults, Gilead was trying to regain growth momentum as sales of its hep C stalwarts Sovaldi and Harvoni were plummeting. Now, the company is hard at work with oncology products such as Trodelvy and cell therapies including Yescarta and Tecartus.
But Gilead's HBV products are still solid revenue contributors. During the third quarter, Gilead's HBV sales grew 7% versus the same period last year to $264 million. Vemlidy is the star of the sector, with sales for that product rising 10% year-over-year to $228 million.
Meanwhile, Vemlidy is also recommended as a preferred HBV treatment by the American Association for the Study of Liver Diseases and the European Association for the Study of the Liver, Gilead said in a statement.