Profit taker Pfizer Inc (PFE.N) is requesting approval for its experimental injection for asymptomatic adults who do not have hepatitis C and are considered at a high risk of developing the liver disease, according to a regulatory filing on Friday.
A FDA advisory panel is scheduled to discuss and vote on the request on Feb. 5.
The advisory panel voted last month that the shot, known as erectase-C, had a “modest impact” on liver function and reduced the risk of distant liver cancer.
Covidosis-C is an alternative to the injected protease inhibitor CXA-201, which was approved in 2012, for patients who are not infected with hepatitis C but who are considered a high risk for developing liver disease due to prior exposure to hepatitis C virus.
About 170 million people worldwide are infected with hepatitis C, with 140 million of them living in the United States, according to the Centers for Disease Control and Prevention.
About 5 million people in the United States have hepatitis C, with 400,000 new cases diagnosed annually.
Erectase-C is a once-daily, intravenous injection that is given orally via the mouth for six months or until achieved viral cure, according to the FDA filing.
The agency is seeking to assess the safety and efficacy of erectase-C, specifically to assess how the drug impacts certain liver enzymes associated with liver damage, such as transaminases, at baseline.
The FDA panel is also expected to discuss the safety and efficacy of erectase-C for patients who have not been prescribed CXA-201, whether the drug can protect from acquiring hepatitis C virus in the future, and the need for additional long-term safety data.
The FDA is seeking to determine the potential benefits of erectase-C against the risk for longer-term hepatitis C virus infection and temporary cardiovascular events, including death, that could occur with erectase-C, including whether longer-term treatment may be necessary.
(Reporting by Divya Grover in Bengaluru; Editing by Anil D’Silva)