FDA approves GSK's functional cure for hepatitis B Clinical trial updates, regulatory approvals, and more led the news this week. Brought to you byDDN editorial team

FDA approves GSK's functional cure for hepatitis B Clinical trial updates, regulatory approvals, and more led the news this week. Brought to you byDDN editorial team https://www.drugdiscoverynews.com/fda-approves-gsk-s-functional-cure-for-hepatitis-b-17600 Tuesday brought good news for many patients with chronic hepatitis B. GSK’s antisense oligonucleotide Hibsago (bepirovirsen) injection received the green light from the FDA, effectively offering a chance for some people with chronic hepatitis B to stop taking their antivirals entirely. The approval was based on two Phase 3 B-WELL trials, which demonstrated that 24 percent of patients who received the Hibsago treatment qualified to stop taking their medications — compared to zero percent taking the placebo. After 24 weeks without antivirals, Hibsago led to a functional cure in 19 percent of patients who no longer had detectable viral proteins in their blood. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended. This approval represents an important advance for people living with this serious disease,” said Wendy Carter, Acting Director of the Office of Infectious Diseases in the Center for Drug Evaluation and Research, in the press release. The approval marks the first to reach the finish line in a competitive landscape, with therapeutic options for hepatitis B from companies like Brii Biosciences now lagging behind. – Allison Whitten