- Japan's MHLW reviews NDA for bepirovirsen, an antisense oligonucleotide for chronic hepatitis B.
- Chronic hepatitis B affects over 250 million globally, with nearly one million cases in Japan.
- Bepirovirsen showed significant functional cure rates in B-Well 1 and 2 Phase III trials.
- SENKU designation in Japan aims for expedited review due to high unmet medical need.
Regulatory Review
Japan's Ministry of Health, Labour and Welfare (MHLW) has accepted a new drug application for bepirovirsen, an investigational antisense oligonucleotide, for treating adults with chronic hepatitis B (CHB).
Chronic Hepatitis B Impact
CHB is a significant public health issue, affecting over 250 million people worldwide, including nearly one million in Japan. Current treatments often require lifelong therapy, with functional cure rates typically at only 1%.
Clinical Trial Results
The regulatory submission is backed by positive results from the B-Well 1 and B-Well 2 Phase III trials. Bepirovirsen showed statistically significant and clinically meaningful functional cure rates, especially in patients with lower baseline hepatitis B surface antigen levels.
SENKU Designation
Bepirovirsen received SENKU designation in Japan in August 2024, highlighting its innovative potential to address a disease with high unmet medical need. This designation aims to expedite the regulatory review process for early patient access.
