The U.S. Food and Drug Administration (FDA) recently granted a fast track designation to Warminster-based biopharmaceutical company Arbutus Biopharma Corp.’s imdusiran, a treatment for chronic hepatitis B (cHBV).
The FDA’s Fast Track program facilitates the development of investigational therapies to treat serious conditions with unmet medical need and expedites the drugs’ reviews. When a drug is granted fast track designation, it is eligible for earlier, more frequent meetings and communications with the FDA. It also has the potential for accelerated approval, priority review or rolling review of a biologics license application or new drug application.
More than 250 million people suffer from cHBV infection, according to World Health Organization estimates, including approximately 2 million people in the United States. Annually,
approximately 1.1 million people die from complications related to cHBV infection.
“We are excited about the potential of imdusiran, which in trials has achieved functional cure for 10 chronic hepatitis B patients to date and allowed many others to live medication-free, to address significant unmet medical need,” Lindsay Androski, Arbutus president and CEO, said.
Imdusiran is an RNAi therapeutic designed to reduce all hepatitis B viral proteins and antigens. The hepatitis B surface antigen is believed to be needed to reawaken a patient’s immune system.