Arbutus Biopharma Corporation Wins FDA Fast Track Status For Chronic Hepatitis B Drug Imdusiran

Arbutus Biopharma Corporation, a clinical-stage biopharmaceutical company focused on infectious diseases, has announced that its investigational therapy imdusiran has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of chronic hepatitis B (cHBV).

The Fast Track designation is intended to support and accelerate the development of therapies that address serious conditions with significant unmet medical needs. It is designed to facilitate closer interaction between companies and the FDA during drug development, helping to potentially speed up the review process for promising treatments.

Arbutus highlighted that imdusiran has shown encouraging clinical results to date. According to the company, the therapy has achieved functional cure in 10 patients with chronic hepatitis B in clinical studies, while also enabling several other patients to remain off medication. These outcomes are being viewed as an important step forward in addressing a disease that continues to represent a major global health burden with limited curative options.

Lindsay Androski, President and Chief Executive Officer of Arbutus, said the company is encouraged by the potential of imdusiran to meet a significant unmet medical need in chronic hepatitis B. She noted that the FDA’s decision to grant Fast Track designation serves as validation of imdusiran as an important investigational therapy. She also added that Arbutus looks forward to working closely and collaboratively with the FDA as the program continues to advance through later stages of development.

Under the FDA’s Fast Track program, qualifying therapies may receive several development advantages, including more frequent meetings and communication with the FDA. Depending on the data and regulatory requirements, Fast Track therapies may also be eligible for additional regulatory benefits such as Priority Review, Accelerated Approval, or Rolling Review when submitting a Biologics License Application or New Drug Application.

Overall, the designation marks an important regulatory milestone for Arbutus as it continues to advance imdusiran as a potential treatment option for patients living with chronic hepatitis B.