Business impact of JACE approval conditions and re-examination results
First written in FY2016. 2 of 4 entries say "Mitigated", first in FY2018-Q1. Latest entry: FY2024.
No other company in this theme has enough history to compare yet.
- FY2024MitigatedAnnual report
「JACE autologous cultured epidermis received marketing authorization in Japan in October 2007 as Japan's first regenerative medicine product for extensive severe burns. In addition, as a result of R&D activities aimed at expanding its indications to new diseases, JACE received a partial-change approval in September 2016 for excision wounds associated with congenital giant pigmented nevi, and another partial-change approval in December 2018 for intractable erosions and ulcers occurring in patients with dystrophic and junctional epidermolysis bullosa.」
The principal JACE approvals and indication expansions have been completed, reducing the previous approval-maintenance risk. However, use-results surveys for the new indications are ongoing. - FY2020RestatedAnnual report
「Post-marketing use-results surveys are required for JACE autologous cultured epidermis, for nevi and epidermolysis bullosa, JACC autologous cultured cartilage, and Nepic autologous cultured corneal epithelium, and these products are subject to re-examination. Depending on the results, the possibility that the approvals could be revoked cannot be completely ruled out.」
The disclosure continues to describe the potential impact of use-results surveys and re-examinations on the approvals of the new JACE indication, JACC and Nepic. - FY2018-Q1MitigatedAnnual report
「In June 2017, the results of the re-examination were reported to the subcommittee, and there were no changes to the indications, efficacy or performance of JACE for severe burns.」
The results of the JACE re-examination were reported, and the absence of changes to its indications, efficacy or performance for severe burns reduced uncertainty surrounding the approval content by one step. - FY2016First statedAnnual report
「If the results of this post-marketing clinical trial reveal a safety or efficacy problem, the approval could be revoked, which could have a material impact on the company's business strategy and business performance. In parallel, the company submitted in January 2015, as re-examination application materials, interim results from the use-results survey covering all cases registered by October 2014 during the 7-year re-examination period.」
The disclosure states that the results of the post-marketing clinical trial, the use-results survey covering all cases and the re-examination could affect the maintenance of the approval and business performance.