FDA approves Gilead’s Vemlidy

Vemlidy, Gilead Sciences’s treatment for chronic hepatitis B virus (HBV) with compensated liver disease, has been approved by the U,S. Food and Drug Administration.
“Chronic hepatitis B is a life-threatening illness that affects up to 2.2 million people in the U.S.,” Vemlidy clinical study investigator Dr. Calvin Pan said. “Clinical trials demonstrated Vemlidy is efficacious with improved renal and bone safety parameters compared to Viread, representing an important development for people living with this chronic disease.”
Vemlidy, which is a once-a-day medication, has a statement on the box to warn of the risk of lactic acidosis/severe hepatomegaly with steatosis and extreme acute exacerbation of HBV that could occur after using the treatment.
“Since the mid-1990s, Gilead has been working to improve and simplify care for people living with chronic hepatitis B,” Gilead Sciences President and Chief Executive Officer John Milligan said. “Vemlidy is the first medication approved to treat this disease in nearly a decade, and we are excited to offer a new, effective option to help advance long-term care for patients.”