Regulatory Gilead Science seeks approval from FDA on HBV Children’s...

Gilead Science seeks approval from FDA on HBV Children’s Medication


It may seem like Gilead Science has shifted its approach towards oncology but they are simultaneously working on other portfolios, most importantly the hepatitis portfolio. One of the major developments of the company is the medication named Vemlidy which is a chronic hepatitis B medication. As per the latest evidence, the medication has gained widespread recognition in terms of its effectiveness in the treatment of liver disease in children.

Gilead Science has been in the industry for over 30 years. They claim that developing medications for niche disorders is their way to differentiate themselves from their competition. 

By the start of this week, the FDA gave approval for the consumption of medication for patients aged 12 and above. Another approval for HBV patients was previously given in 2016 by the FDA, in which the medication which was taken over was Gilead’s older medication Viread.

The approval given by the FDA was based on a 6-month clinical trial data of Phase 2 consisting of 70 simple treatments and treatment-experienced children ages between 12 to 18 years. The results were that more than 20% of the patients had lower hepatitis B DNA levels in comparison to 0% of placebo patients.

According to GoodRx, the average retail price for Vemlidy is $2,034 for 30 tablets, with the lowest retail price of $1,285.

As per Kathleen Schwarz, a gastroenterologist in San Diego, the Long-term hepatitis B virus has severe chronic effects on children followed by a potential chance of developing liver cancer in the later stages of life.

Gilead had seen low sales of their hepatitis C virus medication- Harvoni and Sovaldi- and the company was observed trying to course correct. With this, came the approval of Gilead’s hepatitis B medication approval from the FDA. 

Now, the company has shifted focus to cancer treatments like Trodelvy, as well as cell therapies like Yescarta and Tecartus.

However, Gilead’s HBV medications continue to generate a significant portion of its total revenues. 

The Chief Medical Officer at Gilead stated that while the illness’s frequency has “substantially decreased” in the United States, Gilead is “focused on solving the largest challenges in liver disease” and modifying the course of the disease.

As per the statement released by Gilead, its hepatitis B virus medication Vemlidy has been approved by relevant bodies namely the American Association of Liver Diseases and the European Association for Liver Research.

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