Posted by Michael Wonder on 22 Nov 2021
Gilead submits biologics license application to U.S. Food and Drug Administration for bulevirtide, an investigational treatment for people living with chronic hepatitis delta
19 November 2021 - If approved, bulevirtide will be the first treatment option for adult patients in the U. S. with chronic hepatitis delta virus infection with compensated liver disease.
Gilead Sciences announced today that it has submitted a biologics license application to the U.S. FDA for bulevirtide for injection (2 mg), a potential first-in-class antiviral medicine for the treatment of chronic hepatitis delta virus infection in adults with compensated liver disease; bulevirtide has been granted breakthrough therapy and orphan drug designations by the FDA.
