Clinical Package
・PMDA does not require additional studies in Japan.
• Approval may be based on foreign clinical data, particularly from the CardiAMP Heart Failure Trial.
◾️BioCardia Update on PMDA Consultation for CardiAMP Cell Therapy (Nov 30, 2023)
• Context: BioCardia met with Japan’s PMDA regarding regulatory approval of its CardiAMP autologous cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF).
• Preclinical Package: PMDA requested additional details; BioCardia believes these are easily addressable.
●Clinical Package:
・PMDA does not require additional studies in Japan.
・Approval may be based on foreign clinical data, particularly from the CardiAMP Heart Failure Trial.
• PMDA wants to review interim and final trial results.
●Indication Scope:
Initial approval may be limited to patients with NT-proBNP > 500 pg/ml, consistent with FDA-approved criteria for CardiAMP Heart Failure II.
• Next Steps:
・Formal meeting minutes expected in four weeks.
• Follow-up consultation planned.
●CEO Statement:
Peter Altman, PhD, emphasized the therapy’s minimally invasive nature and its potential to offer a safer alternative to open-heart cell therapies currently used in Japan.
2年前の重要なニュースを見落としていた。
日本PMDAは国内追加試験は不要と示唆済み。
BioCardia のCardiAMP-HF試験は、クオリプスと同じ NYHA クラス II–III の虚血性心筋症による慢性心不全を対象とし、しかも大規模シャム対照試験で長期的有効性を検証した実績があります。
クオリプスの心筋シートが Phase 2b 申請中に希少疾病用製品として指定された事例を踏まえれば、BioCardiaのカテーテル細胞療法に関する医療機器も、少なくとも、優先審査指定等の規制上の支援措置を適用するのが公平です。さもなくば、国内外から「日本の規制当局は整合性に欠ける」「外資系に不利だ」との評価を受けかねません。
2025年第4QPMDAとの協議結果に注視です🍵
Clinical Package
・PMDA does not require additional studies in Japan.
• Approval may be based on foreign clinical data, particularly from the CardiAMP Heart Failure Trial.
◾️BioCardia Update on PMDA Consultation for CardiAMP Cell Therapy (Nov 30, 2023)
• Context: BioCardia met with Japan’s PMDA regarding regulatory approval of its CardiAMP autologous cell therapy for ischemic heart failure with reduced ejection fraction (HFrEF).
• Preclinical Package: PMDA requested additional details; BioCardia believes these are easily addressable.
●Clinical Package:
・PMDA does not require additional studies in Japan.
・Approval may be based on foreign clinical data, particularly from the CardiAMP Heart Failure Trial.
• PMDA wants to review interim and final trial results.
●Indication Scope:
Initial approval may be limited to patients with NT-proBNP > 500 pg/ml, consistent with FDA-approved criteria for CardiAMP Heart Failure II.
• Next Steps:
・Formal meeting minutes expected in four weeks.
• Follow-up consultation planned.
●CEO Statement:
Peter Altman, PhD, emphasized the therapy’s minimally invasive nature and its potential to offer a safer alternative to open-heart cell therapies currently used in Japan.
投資の参考になりましたか？