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Transthyretin (ATTR) amyloidosis: 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Transthyretin (ATTR) amyloidosis clinical trial

국가별 선택지

국가별 치료 선택지

공식 규제·평가 기관 출처를 바탕으로 한 국가별 승인·접근 상태입니다. 무엇이 어디에 존재하는지를 보여줄 뿐, 추천이 아닙니다.

United States

  • tafamidis meglumine / tafamidis (Vyndaqel / Vyndamax); acoramidis (Attruby); vutrisiran (Amvuttra); patisiran (Onpattro); eplontersen (Wainua); inotersen (Tegsedi)[1]FDA-approvedTTR amyloid deposition; hereditary TTR variant when hATTR/ATTRv is specified; wild-type ATTR-CM when no TTR mutation; Adult ATTR-CM cardiomyopathy disease-modifying therapy; adult hereditary ATTR polyneuropathy disease-modifying TTR-silencing/antisense therapy. · ATTR-CM and hATTR-PN indications are not interchangeable. Tafamidis/acoramidis are stabilizer options; vutrisiran/patisiran/eplontersen/inotersen reduce TTR production by RNA-directed mechanisms. Tegsedi label includes REMS/laboratory-monitoring caveats. Labels do not establish payer access, sequencing, or combination therapy. Confidence/conflicts: High for U.S. FDA/DailyMed indications. No sequencing, superiority, or combination claim is made.
  • tafamidis meglumine / tafamidis (Vyndaqel / Vyndamax); acoramidis (Attruby); vutrisiran (Amvuttra); patisiran (Onpattro); eplontersen (Wainua); inotersen (Tegsedi)[1]FDA-approvedTTR amyloid deposition; hereditary TTR variant when hATTR/ATTRv is specified; wild-type ATTR-CM when no TTR mutation; Adult ATTR-CM cardiomyopathy disease-modifying therapy; adult hereditary ATTR polyneuropathy disease-modifying TTR-silencing/antisense therapy. · ATTR-CM and hATTR-PN indications are not interchangeable. Tafamidis/acoramidis are stabilizer options; vutrisiran/patisiran/eplontersen/inotersen reduce TTR production by RNA-directed mechanisms. Tegsedi label includes REMS/laboratory-monitoring caveats. Labels do not establish payer access, sequencing, or combination therapy. Confidence/conflicts: High for U.S. FDA/DailyMed indications. No sequencing, superiority, or combination claim is made.
  • tafamidis meglumine / tafamidis (Vyndaqel / Vyndamax); acoramidis (Attruby); vutrisiran (Amvuttra); patisiran (Onpattro); eplontersen (Wainua); inotersen (Tegsedi)[1]FDA-approvedTTR amyloid deposition; hereditary TTR variant when hATTR/ATTRv is specified; wild-type ATTR-CM when no TTR mutation; Adult ATTR-CM cardiomyopathy disease-modifying therapy; adult hereditary ATTR polyneuropathy disease-modifying TTR-silencing/antisense therapy. · ATTR-CM and hATTR-PN indications are not interchangeable. Tafamidis/acoramidis are stabilizer options; vutrisiran/patisiran/eplontersen/inotersen reduce TTR production by RNA-directed mechanisms. Tegsedi label includes REMS/laboratory-monitoring caveats. Labels do not establish payer access, sequencing, or combination therapy. Confidence/conflicts: High for U.S. FDA/DailyMed indications. No sequencing, superiority, or combination claim is made.

European Union

  • tafamidis (Vyndaqel); acoramidis (Beyonttra); vutrisiran (Amvuttra)[2]EMA authorisedvariant/hereditary ATTR for stage 1 or 2 polyneuropathy; variant or wild-type ATTR-CM for cardiomyopathy; Adult ATTR-CM disease-modifying therapy; adult hereditary ATTR polyneuropathy stage 1 or 2 for Amvuttra/Vyndaqel contexts as stated by EMA. · EMA authorisation does not equal member-state reimbursement. NICE applies to NHS England/Wales-type commissioning contexts and includes commercial-arrangement language. Country-specific France/Germany reimbursement for Beyonttra and Amvuttra remains to verify. Confidence/conflicts: High for EMA/NICE claims. Vyndaqel EMA summary page emphasizes early-stage polyneuropathy while current product information has later updates; deeper SmPC indication parsing remains a follow-up.
  • tafamidis (Vyndaqel); acoramidis (Beyonttra); vutrisiran (Amvuttra)[2]EMA authorisedvariant/hereditary ATTR for stage 1 or 2 polyneuropathy; variant or wild-type ATTR-CM for cardiomyopathy; Adult ATTR-CM disease-modifying therapy; adult hereditary ATTR polyneuropathy stage 1 or 2 for Amvuttra/Vyndaqel contexts as stated by EMA. · EMA authorisation does not equal member-state reimbursement. NICE applies to NHS England/Wales-type commissioning contexts and includes commercial-arrangement language. Country-specific France/Germany reimbursement for Beyonttra and Amvuttra remains to verify. Confidence/conflicts: High for EMA/NICE claims. Vyndaqel EMA summary page emphasizes early-stage polyneuropathy while current product information has later updates; deeper SmPC indication parsing remains a follow-up.
  • tafamidis (Vyndaqel); acoramidis (Beyonttra); vutrisiran (Amvuttra)[2]EMA authorisedvariant/hereditary ATTR for stage 1 or 2 polyneuropathy; variant or wild-type ATTR-CM for cardiomyopathy; Adult ATTR-CM disease-modifying therapy; adult hereditary ATTR polyneuropathy stage 1 or 2 for Amvuttra/Vyndaqel contexts as stated by EMA. · EMA authorisation does not equal member-state reimbursement. NICE applies to NHS England/Wales-type commissioning contexts and includes commercial-arrangement language. Country-specific France/Germany reimbursement for Beyonttra and Amvuttra remains to verify. Confidence/conflicts: High for EMA/NICE claims. Vyndaqel EMA summary page emphasizes early-stage polyneuropathy while current product information has later updates; deeper SmPC indication parsing remains a follow-up.

Japan

  • acoramidis (Beyonttra); patisiran (Onpattro)[3]PMDA-approved (Japan)wild-type or variant ATTR-CM for acoramidis; hereditary TTR amyloidosis for patisiran; Adult ATTR-CM acoramidis stabilizer context; hATTR polyneuropathy patisiran context. · Acoramidis PMDA document is fetched regulator review material, but the exact Japan package-insert indication/reimbursement should still be checked. Onpattro Japan approval is manufacturer-announcement sourced, not a direct PMDA label in this pass. Confidence/conflicts: Medium-high for Japan acoramidis because PMDA review and manufacturer announcement align; medium for Japan patisiran until PMDA label is fetched.
  • acoramidis (Beyonttra); patisiran (Onpattro)[3]PMDA-approved (Japan)wild-type or variant ATTR-CM for acoramidis; hereditary TTR amyloidosis for patisiran; Adult ATTR-CM acoramidis stabilizer context; hATTR polyneuropathy patisiran context. · Acoramidis PMDA document is fetched regulator review material, but the exact Japan package-insert indication/reimbursement should still be checked. Onpattro Japan approval is manufacturer-announcement sourced, not a direct PMDA label in this pass. Confidence/conflicts: Medium-high for Japan acoramidis because PMDA review and manufacturer announcement align; medium for Japan patisiran until PMDA label is fetched.
  • tafamidis (Vyndamax) / tafamidis meglumine (Vyndaqel)[4]PMDA-approved (Japan)transthyretin (TTR); source refers to wild-type or hereditary transthyretin-mediated amyloidosis cardiomyopathy; adult ATTR-CM, wild-type or hereditary, with cardiovascular mortality and cardiovascular-related hospitalization endpoint language in the prescribing-information text. · The PMDA material includes non-Japanese source labeling within the review package and Japanese review context; Japanese original labeling should be checked before patient-facing reuse. This entry does not establish Japanese reimbursement, center access, cardiac diagnostic workup, or whether ATTR polyneuropathy therapy options are covered in the same pathway. Confidence/conflicts: Medium-high for Japanese PMDA source package supporting ATTR-CM tafamidis approval context; no conflict identified. Japanese final package insert/reimbursement details remain gaps.

Australia

  • tafamidis / tafamidis meglumine (Vyndamax / Vyndaqel)[5]TGA-registered (Australia)TTR amyloid; hereditary or wild-type ATTR-CM; adult wild-type or hereditary ATTR-CM in Australia. · TGA verifies registration and approved therapeutic use but does not establish PBS subsidy, diagnostic criteria, genotype testing, or specialist access rules. Confidence/conflicts: High for Australian approved indication; reimbursement/access remains source-pending. No conflict identified.
  • vutrisiran (Amvuttra)[6]TGA-registered (Australia)pathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with stage 1 or stage 2 polyneuropathy in Australia. · The AusPAR states the indication was narrowed to patients studied in HELIOS-A, namely stage 1 or 2 polyneuropathy. These sources do not establish cardiomyopathy approval in Australia; a separate new-indication application was under evaluation in a fetched TGA page. Confidence/conflicts: High for Australia hATTR-PN approval; ATTR-CM status remains source-pending/new-indication under evaluation. No conflict identified. Availability/reimbursement outside the approving regulator not established.
  • vutrisiran (Amvuttra)[6]TGA-registered (Australia)pathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with stage 1 or stage 2 polyneuropathy in Australia. · The AusPAR states the indication was narrowed to patients studied in HELIOS-A, namely stage 1 or 2 polyneuropathy. These sources do not establish cardiomyopathy approval in Australia; a separate new-indication application was under evaluation in a fetched TGA page. Confidence/conflicts: High for Australia hATTR-PN approval; ATTR-CM status remains source-pending/new-indication under evaluation. No conflict identified. Availability/reimbursement outside the approving regulator not established.

Thailand

  • tafamidis (Vyndamax)[7]Approvedtransthyretin (TTR); source states etiologic confirmation should exclude AL amyloidosis and characterize wild-type or hereditary ATTR with assessment tools including scintigraphy, blood/urine assessment and/or biopsy, and TTR genotyping; adult patients with wild-type or hereditary ATTR-CM; source states treatment should be initiated under supervision of a physician knowledgeable in amyloidosis or cardiomyopathy and that tafamidis should be added to standard of care. · The label states ATTR-CM should be confirmed and AL amyloidosis excluded before treatment. It notes limited clinical data in NYHA Class IV, physician discretion in more advanced amyloid-related cardiac damage such as NYHA Class III, no data for organ transplantation with discontinuation if organ transplantation occurs, and no relevant pediatric use. This entry does not establish Thai reimbursement, hospital formulary availability, or hereditary-polyneuropathy indications. Confidence/conflicts: High for Thai Vyndamax ATTR-CM label content; no conflict identified. Access/reimbursement and non-cardiomyopathy ATTR indications remain unresolved.

Canada

  • patisiran (Onpattro)[8]Health Canada approvedpathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with polyneuropathy in Canada. · The SBD verifies the polyneuropathy indication and notes pediatric use was not authorized. It does not establish routine coverage, choice versus vutrisiran, or cardiomyopathy treatment. Confidence/conflicts: High for Canadian patisiran marketed status and approved hATTR-PN indication; reimbursement and sequencing remain source-pending. No conflict identified.
  • patisiran (Onpattro)[8]Health Canada approvedpathogenic TTR variant / hereditary ATTR; adult hATTR amyloidosis with polyneuropathy in Canada. · The SBD verifies the polyneuropathy indication and notes pediatric use was not authorized. It does not establish routine coverage, choice versus vutrisiran, or cardiomyopathy treatment. Confidence/conflicts: High for Canadian patisiran marketed status and approved hATTR-PN indication; reimbursement and sequencing remain source-pending. No conflict identified.
  • tafamidis meglumine (Vyndaqel)[9]Health Canada approvedTTR amyloid; wild-type or hereditary ATTR-CM; adult wild-type or hereditary ATTR-CM in Canada. · Health Canada has not authorized pediatric use. The sources verify label/authorization but not provincial reimbursement or sequencing versus acoramidis or vutrisiran. Confidence/conflicts: High for Canadian tafamidis ATTR-CM authorization; reimbursement not established. No conflict identified.
  • vutrisiran (Amvuttra)[10]Health Canada approvedTTR amyloid; hATTR with stage 1/2 polyneuropathy; wild-type or hereditary ATTR-CM; adult hATTR stage 1/2 polyneuropathy and adult wtATTR or hATTR cardiomyopathy in Canada. · Product portal status date reflects the original marketed product record, while the fetched current monograph includes the later cardiomyopathy indication and date of authorization 2025-12-12 in patient information. CADTH/provincial coverage for the cardiomyopathy indication remains source-pending. Confidence/conflicts: High for current Canadian monograph indications and marketed status; reimbursement and implementation remain source-pending. No conflict identified.
  • vutrisiran (Amvuttra)[10]Health Canada approvedTTR amyloid; hATTR with stage 1/2 polyneuropathy; wild-type or hereditary ATTR-CM; adult hATTR stage 1/2 polyneuropathy and adult wtATTR or hATTR cardiomyopathy in Canada. · Product portal status date reflects the original marketed product record, while the fetched current monograph includes the later cardiomyopathy indication and date of authorization 2025-12-12 in patient information. CADTH/provincial coverage for the cardiomyopathy indication remains source-pending. Confidence/conflicts: High for current Canadian monograph indications and marketed status; reimbursement and implementation remain source-pending. No conflict identified.

출처

  1. U.S. Food and Drug Administration — official drug label · official drug label
  2. European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
  3. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review report · regulator review report
  4. Pharmaceuticals and Medical Devices Agency (PMDA) — regulator review/application document PDF · regulator review/application document PDF
  5. Therapeutic Goods Administration (TGA) — Australian Prescription Medicine Decision Summary · Australian Prescription Medicine Decision Summary
  6. Therapeutic Goods Administration (TGA) — Australian Prescription Medicine Decision Summary · Australian Prescription Medicine Decision Summary
  7. Thai National Drug Information / Thai FDA-MOPH — local product document / regulator drug-information repository PDF · local product document / regulator drug-information repository PDF
  8. Health Canada Drug Product Database — drug product database record · drug product database record
  9. Health Canada Drug and Health Products Portal — Summary Basis of Decision · Summary Basis of Decision
  10. Health Canada Drug and Health Products Portal — drug product portal record · drug product portal record

위 내용은 공식 규제·접근 상태일 뿐, 의학적 조언이나 추천이 아니고, 적격성을 판단하지도 않습니다. 어떤 선택지가 적합한지는 환자의 상황과 종양내과 팀에 달려 있습니다. 규제 상태는 바뀔 수 있으니 표시된 출처에서 확인하세요. 임상 세부 내용은 영문이 정본입니다. 최종 확인 2026-06-12.