再生医療等製品・生物由来技術部会で審議した結果、条件及び期限付承認時に設定した達成基準を満たさず、ハートシートを承認することは適切ではないと判断されました。なお、ハートシートの安全性については、条件及び期限付承認時に確認されたリスクや有害事象を超える新たな懸念は認められませんでした。
TopTerumo Corporation (Headquarters: Shibuya-ku, Tokyo; President: Hikaru Samejima) has announced that the regenerative medical product "Heart Sheet" for heart failure treatment has been judged as inappropriate for approval by the Pharmaceutical Affairs and Food Sanitation Council (Regenerative Medical Product and Biological Technique Subcommittee) of the Ministry of Health, Labor and Welfare held on July 19th this year.
Terumo obtained conditional and time-limited manufacturing and sales approval (conditional and time-limited approval) for Heart Sheet in September 2015, and conducted efficacy surveys targeting all cases that used Heart Sheet based on the conditions attached at that time, as well as clinical studies targeting heart failure patients who did not receive Heart Sheet transplantation. Based on the comparison and evaluation of information obtained in these efficacy surveys and clinical studies (post-approval evaluation of manufacturing and sales conditions), Terumo re-applied for manufacturing and sales approval in September last year.
As a result of the review by the Regenerative Medical Product and Biological Technique Subcommittee, it was judged that Heart Sheet does not meet the achievement criteria set at the time of the conditional and time-limited approval, and that approval of Heart Sheet is not appropriate. However, no new concerns were found regarding the safety of Heart Sheet beyond the risks and adverse events confirmed at the time of conditional and time-limited approval.
After receiving the results of the review, Terumo has discontinued the sales of Heart Sheet and will continue to conduct efficacy surveys of patients who have already received Heart Sheet in collaboration with medical institutions. Regarding the results of the efficacy surveys and clinical studies used for the manufacturing and sales approval application, we plan to publish the information through medical journals and other means.
Terumo started research and development of Heart Sheet in 2003, and has been working on the establishment of manufacturing and quality control processes, conducting clinical trials, and introducing it to the market to deliver new treatment options for patients with severe heart failure who do not have any effective treatments other than heart transplantation. Based on the valuable scientific knowledge obtained through these activities, Terumo will continue to develop regenerative medical products and contribute to the evolution of medical care and improvement of QOL for patients.
(Reference) Deliberation content at the Regenerative Medical Product and Biological Technique Subcommittee on July 19th
Cardiovascular-related death
- Period from the occurrence of any serious cardiovascular event※1 until hospitalization
- Percentage of cases in which LVEF※2 improved by 5% or more from the time of Heart Sheet transplantation after 6 months
Heart Sheet Group: Efficacy Survey 67 cases/49 cases
Control Group (Reference Group): Clinical Study 104 cases/102 cases
- Although the data from the clinical study referred to was an external control and there were limitations in comparing the two groups even after adjusting for this, there was no indication of superiority of the Heart Sheet group over the control group (reference group) regarding the period until the main evaluation item, cardiovascular-related death.
- There was no significant difference in the improvement of LVEF related to cardiac function, which is a secondary evaluation item, between the Heart Sheet group and the control group (reference group).
- Although no new concerns were found regarding the safety of Heart Sheet beyond the risks and adverse events confirmed at the time of conditional and time-limited approval, it is not acceptable from the perspective of benefit-risk that the efficacy of Heart Sheet has not been demonstrated.
Overview of Terumo Corporation
Terumo is a medical device manufacturer with a 100-year history, with the philosophy of 'contributing to society through medical care.' It has its headquarters in Japan and is active in more than 160 countries and regions around the world, with more than 30,000 associates working every day to deliver innovative solutions.
Starting with the production of domestically made thermometers, Terumo has continued to support the foundation of medical care. Currently, it provides a wide range of products and services related to catheter treatment, cardiovascular surgery, drug administration, diabetes management, peritoneal dialysis, transfusion and cell therapy.
Terumo aims to be a valuable company for society, including patients and healthcare professionals.
A press release is intended to provide fair and appropriate information to stakeholders about our company's information. Product information (including under development) in the text is not intended for customer solicitation or medical advice.
In addition, descriptions of the future, including expected business performance, are based on information currently available to us and certain assumptions that we consider to be reasonable, and are not intended to promise their realization on our part. Please note that various factors may cause actual business performance to fluctuate. Important factors that could affect actual performance include changes in economic conditions surrounding Terumo's business areas, fluctuations in exchange rates, and competitive conditions.
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