CSL Behring’s BERINERT SC was approved for prevention of acute hereditary angioedema attacks, HAE, in September 2022.
Efficacy and safety of the product based on results of COMPACT study, global Ph 3, COMPACT extension study and Japanese Ph 3 study were evaluated by PMDA. The duration of Japanese Ph 3 study was around 10 months.
According to the quarterly price listing report published in October 2022, BERINERT SC was priced based on TAKHZYRO, marketed by Takeda since March 2022, that means it was given the same price as TAKHZYRO’s in terms of daily price. CSL Behring expects 36M USD as peak sales in the 4th year treating 139 HAE patients.
In Japan, drug pricing is regulated by the government because Japan has a universal healthcare system and the government controls healthcare expenditure including drug costs.
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) – Full Text View – ClinicalTrials.gov