Bond.az -- Gilead Sciences (NASDAQ:GILD) announced on Friday that the U.S. Food and Drug Administration has approved Hepcludex, its experimental drug for chronic hepatitis delta virus. The approval marks the first FDA-approved therapy for the rare and deadly liver infection.
Shares of Gilead Sciences rose more than 2% in afternoon trading following the announcement.
Hepcludex is approved to treat chronic hepatitis delta virus, or HDV, a liver disease that occurs only in people already infected with hepatitis B. The condition can lead to liver scarring, cancer, organ failure and death.
Between 40,000 and 80,000 people in the United States are estimated to be living with the disease, according to Gilead Sciences.
"Today's approval fills a critical gap in care for patients with chronic HDV infection, who until now have had no FDA-approved therapies available," said Wendy Carter, acting director of the Office of Infectious Diseases in FDA's Center for Drug Evaluation and Research.
The FDA based its approval on results from a late-stage trial. In the study, approximately 48% of patients who received Hepcludex showed meaningful improvement after 48 weeks, compared with 2% of those whose treatment was delayed. The trial also showed that the virus became undetectable in patients the longer they remained on Hepcludex.
