This article is more than 5 years old. Information may no longer be current.
FDA fast tracks interferon Lambda for HDV
The FDA has granted fast track status to Lambda as a possible treatment for chronic hepatitis delta virus, the interferon’s manufacturer, Eiger BioPharmaceuticals, announced.
“We are very pleased that the FDA has granted Lambda with fast track status for the treatment of HDV,” Eiger president and CEO David Cory said in a news release. “Receiving fast track status is an important achievement that we hope may facilitate and expedite its development as a treatment for HDV.”
Lamda (pegylated interferon lambda-1a) has been administered for hepatitis B and C viruses in clinical trials but has not been approved for an indication. Eiger licensed rights worldwide to the interferon from Bristol-Myers Squibb in 2016.
HDV is a severe form of hepatitis that can occur in people with HBV and is associated with liver cancer and liver failure, among other comorbidities. It is uncommon in the United States, according to the CDC. WHO estimates that approximately 15 million worldwide are chronically coinfected with HDV and HBV.
References:
CDC. Hepatitis D. https://www.cdc.gov/hepatitis/hdv/index.htm. Accessed July 27, 2017.
WHO. Hepatitis D. http://www.who.int/mediacentre/factsheets/hepatitis-d/en/. Accessed July 27, 2017.
Disclosure: Cory is president and CEO of Eiger BioPharmaceuticals.