A novel regenerative medicine for a severe cardiovascular disease, initially granted a conditional approval in Japan almost a decade ago, will exit the market due to challenges meeting the terms of the regulatory pathway.
Key Takeaways
- Terumo’s HeartSheet could not convert its conditional approval in Japan to a full approval after failing to demonstrate efficacy and the company now is planning to pull it from the market.
- A limited number of patients for the confirmatory trial posed a major challenge and caused the conditional period to be extended
Major Japanese medtech firm Terumo Corporation now is preparing to withdraw HeartSheet, an autologous skeletal myoblast-derived cell sheet, from the market