Gilead Sciences Inc. announced that the U.S. Food and Drug Administration (FDA) has expanded its approval for the use of its chronic hepatitis B infection treatment, Vemlidy, in children aged 12 years and older.
This decision by the FDA is based on data from a clinical trial that showed Vemlidy to be safe and effective in treating chronic hepatitis B in children. The trial included 100 children aged 12 to 17 years old who had been diagnosed with chronic hepatitis B and had not received any prior treatment.
Vemlidy, also known as tenofovir alafenamide, is an oral antiviral medication that works by blocking the replication of the hepatitis B virus in the body. It was first approved by the FDA in 2016 for the treatment of chronic hepatitis B in adults.
According to Gilead, chronic hepatitis B is a serious and potentially life-threatening liver infection that affects an estimated 2.2 million people in the United States. It is caused by the hepatitis B virus and can lead to liver damage, cirrhosis, and even liver cancer if left untreated.
The expansion of Vemlidy’s approval to include children is a significant development in the treatment of chronic hepatitis B. Prior to this, there were limited treatment options available for children with this condition, and many had to rely on off-label use of medications approved for adults.
Dr. John McHutchison, Chief Scientific Officer and Head of Research and Development at Gilead, stated, “The expanded approval of Vemlidy provides an important treatment option for children living with chronic hepatitis B, a potentially life-threatening disease.”
The safety and efficacy of Vemlidy in children were evaluated in a 48-week, open-label clinical trial. The results showed that 93% of the participants achieved a virologic response, meaning that the virus was no longer detectable in their blood. Additionally, Vemlidy was well-tolerated with a safety profile similar to that seen in adults.
The FDA’s decision to expand Vemlidy’s approval is a testament to the effectiveness and safety of this treatment in children. It also highlights the importance of continued research and development in the field of pediatric medicine.
Gilead is committed to improving the lives of patients with chronic hepatitis B and other serious diseases. With this expanded approval, Vemlidy can now provide hope and relief to children living with this condition and their families.
In conclusion, the FDA’s decision to expand the approval of Vemlidy for the treatment of chronic hepatitis B in children is a significant step forward in the fight against this disease. It not only provides a much-needed treatment option for children, but also highlights the importance of investing in research and development to improve the lives of patients. Gilead’s commitment to innovation and patient care is evident in this latest development, and it is a promising sign for the future of pediatric medicine.
