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Amyotrophic lateral sclerosis (ALS): 국가별 선택지

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선택지 정리됨희귀·유전 질환최종 확인 2026.06

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임상시험 검색어

Amyotrophic lateral sclerosis (ALS) 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

Riluzole / Rilutek and generics; edaravone / Radicava and Radicava ORS; tofersen / Qalsody; sodium phenylbutyrate plus taurursodiol / Relyvrio noted as withdrawn/discontinued for new U.S. patients [1]FDA-approvedSOD1 mutation for tofersen; no biomarker restriction captured for riluzole or edaravone; Adult ALS for edaravone; ALS generally for riluzole; SOD1 mutation-associated ALS for tofersen. · Tofersen is accelerated approval and continued approval is contingent on confirmatory evidence. Relyvrio is recorded as withdrawn/discontinued for new U.S. patients, so it is not cataloged as a current treatment option except as an access-history caveat. Confidence/conflicts: High for current U.S. riluzole, edaravone, tofersen, and Relyvrio withdrawal/discontinuation status. No source conflict identified. Riluzole (Rilutek/generics) and edaravone (Radicava/Radicava ORS) are FDA-approved, marketed ALS standard-of-care disease-modifying drugs. Tofersen (Qalsody) is under FDA accelerated approval for SOD1-mutation ALS; continued approval is contingent on the ongoing ATLAS confirmatory trial. ONLY Relyvrio (sodium phenylbutyrate + taurursodiol / AMX0035) was withdrawn — it failed the Phase 3 PHOENIX trial and FDA withdrew its NDA approval effective 29 Aug 2025; it is not a current option except as access history. The 'did not show benefit' framing applies to Relyvrio alone, never to riluzole/edaravone/tofersen.
Riluzole / Rilutek and generics; edaravone / Radicava and Radicava ORS; tofersen / Qalsody; sodium phenylbutyrate plus taurursodiol / Relyvrio noted as withdrawn/discontinued for new U.S. patients [1]FDA-approvedSOD1 mutation for tofersen; no biomarker restriction captured for riluzole or edaravone; Adult ALS for edaravone; ALS generally for riluzole; SOD1 mutation-associated ALS for tofersen. · Tofersen is accelerated approval and continued approval is contingent on confirmatory evidence. Relyvrio is recorded as withdrawn/discontinued for new U.S. patients, so it is not cataloged as a current treatment option except as an access-history caveat. Confidence/conflicts: High for current U.S. riluzole, edaravone, tofersen, and Relyvrio withdrawal/discontinuation status. No source conflict identified. Riluzole (Rilutek/generics) and edaravone (Radicava/Radicava ORS) are FDA-approved, marketed ALS standard-of-care disease-modifying drugs. Tofersen (Qalsody) is under FDA accelerated approval for SOD1-mutation ALS; continued approval is contingent on the ongoing ATLAS confirmatory trial. ONLY Relyvrio (sodium phenylbutyrate + taurursodiol / AMX0035) was withdrawn — it failed the Phase 3 PHOENIX trial and FDA withdrew its NDA approval effective 29 Aug 2025; it is not a current option except as access history. The 'did not show benefit' framing applies to Relyvrio alone, never to riluzole/edaravone/tofersen.
Riluzole / Rilutek and generics; edaravone / Radicava and Radicava ORS; tofersen / Qalsody; sodium phenylbutyrate plus taurursodiol / Relyvrio noted as withdrawn/discontinued for new U.S. patients [1]FDA-approvedSOD1 mutation for tofersen; no biomarker restriction captured for riluzole or edaravone; Adult ALS for edaravone; ALS generally for riluzole; SOD1 mutation-associated ALS for tofersen. · Tofersen is accelerated approval and continued approval is contingent on confirmatory evidence. Relyvrio is recorded as withdrawn/discontinued for new U.S. patients, so it is not cataloged as a current treatment option except as an access-history caveat. Confidence/conflicts: High for current U.S. riluzole, edaravone, tofersen, and Relyvrio withdrawal/discontinuation status. No source conflict identified. Riluzole (Rilutek/generics) and edaravone (Radicava/Radicava ORS) are FDA-approved, marketed ALS standard-of-care disease-modifying drugs. Tofersen (Qalsody) is under FDA accelerated approval for SOD1-mutation ALS; continued approval is contingent on the ongoing ATLAS confirmatory trial. ONLY Relyvrio (sodium phenylbutyrate + taurursodiol / AMX0035) was withdrawn — it failed the Phase 3 PHOENIX trial and FDA withdrew its NDA approval effective 29 Aug 2025; it is not a current option except as access history. The 'did not show benefit' framing applies to Relyvrio alone, never to riluzole/edaravone/tofersen.

European Union

Riluzole / Rilutek; tofersen / Qalsody; supportive care including physical, occupational or speech therapy and breathing support as described by EMA [2]EMA authorisedSOD1 mutation for Qalsody/tofersen; ALS form of MND for riluzole; adult SOD1 mutation-associated ALS for Qalsody/tofersen; symptom and breathing support alongside disease-modifying options. · EMA notes EU-wide authorization and member-state price/reimbursement decisions are separate. NICE TA20 is older but remains an official appraisal for riluzole; it does not establish tofersen NHS reimbursement. Confidence/conflicts: High for EU Qalsody and UK riluzole claims; UK tofersen reimbursement remains source-pending.
Riluzole / Rilutek; tofersen / Qalsody; supportive care including physical, occupational or speech therapy and breathing support as described by EMA [2]EMA authorisedSOD1 mutation for Qalsody/tofersen; ALS form of MND for riluzole; adult SOD1 mutation-associated ALS for Qalsody/tofersen; symptom and breathing support alongside disease-modifying options. · EMA notes EU-wide authorization and member-state price/reimbursement decisions are separate. NICE TA20 is older but remains an official appraisal for riluzole; it does not establish tofersen NHS reimbursement. Confidence/conflicts: High for EU Qalsody and UK riluzole claims; UK tofersen reimbursement remains source-pending.
Riluzole / Rilutek; tofersen / Qalsody; supportive care including physical, occupational or speech therapy and breathing support as described by EMA [2]EMA authorisedSOD1 mutation for Qalsody/tofersen; ALS form of MND for riluzole; adult SOD1 mutation-associated ALS for Qalsody/tofersen; symptom and breathing support alongside disease-modifying options. · EMA notes EU-wide authorization and member-state price/reimbursement decisions are separate. NICE TA20 is older but remains an official appraisal for riluzole; it does not establish tofersen NHS reimbursement. Confidence/conflicts: High for EU Qalsody and UK riluzole claims; UK tofersen reimbursement remains source-pending.

Japan

Tofersen / Qalsody; riluzole; edaravone; mecobalamin; symptomatic medications such as opioids for respiratory distress/suffering and antispasmodics for spasm as described in PMDA review discussion [3]PMDA-approved (Japan)SOD1 mutation for tofersen; SOD1 mutation-associated ALS for tofersen; ALS treatment context for riluzole, edaravone, and mecobalamin. · PMDA English translation is reference material and Japanese original takes precedence. PMDA notes patient selection should be by physicians with adequate knowledge and experience in ALS treatment, with benefit-risk assessment for individual patients. Confidence/conflicts: High for Japan tofersen review and PMDA-stated local ALS treatment landscape; no conflict identified. Availability/reimbursement outside the approving regulator not established.
Tofersen / Qalsody; riluzole; edaravone; mecobalamin; symptomatic medications such as opioids for respiratory distress/suffering and antispasmodics for spasm as described in PMDA review discussion [3]PMDA-approved (Japan)SOD1 mutation for tofersen; SOD1 mutation-associated ALS for tofersen; ALS treatment context for riluzole, edaravone, and mecobalamin. · PMDA English translation is reference material and Japanese original takes precedence. PMDA notes patient selection should be by physicians with adequate knowledge and experience in ALS treatment, with benefit-risk assessment for individual patients. Confidence/conflicts: High for Japan tofersen review and PMDA-stated local ALS treatment landscape; no conflict identified. Availability/reimbursement outside the approving regulator not established.
Tofersen / Qalsody; riluzole; edaravone; mecobalamin; symptomatic medications such as opioids for respiratory distress/suffering and antispasmodics for spasm as described in PMDA review discussion [3]PMDA-approved (Japan)SOD1 mutation for tofersen; SOD1 mutation-associated ALS for tofersen; ALS treatment context for riluzole, edaravone, and mecobalamin. · PMDA English translation is reference material and Japanese original takes precedence. PMDA notes patient selection should be by physicians with adequate knowledge and experience in ALS treatment, with benefit-risk assessment for individual patients. Confidence/conflicts: High for Japan tofersen review and PMDA-stated local ALS treatment landscape; no conflict identified. Availability/reimbursement outside the approving regulator not established.

Australia

riluzole (Rilutek)[4]ApprovedALS treatment in Australia, as stated by the Australian product information. · The product information includes hepatic, pregnancy/lactation, and pediatric caveats; this entry records label status only, not PBS subsidy or individual suitability. Confidence/conflicts: High for Australian riluzole label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
riluzole (Rilutek)[4]ApprovedALS treatment in Australia, as stated by the Australian product information. · The product information includes hepatic, pregnancy/lactation, and pediatric caveats; this entry records label status only, not PBS subsidy or individual suitability. Confidence/conflicts: High for Australian riluzole label status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
tofersen (Qalsody)[5]TGA-registered (Australia)mutation/defect in the superoxide dismutase 1 (SOD1) gene; adult SOD1-associated ALS in Australia. · The approval is provisional. The TGA source describes SOD1-ALS as a rare ALS form and records regulatory status, not payer access, genetic-testing access, or individual suitability. Confidence/conflicts: High for Australian provisional-approval status; no conflict identified. Availability/reimbursement outside the approving regulator not established.
tofersen (Qalsody)[5]TGA-registered (Australia)mutation/defect in the superoxide dismutase 1 (SOD1) gene; adult SOD1-associated ALS in Australia. · The approval is provisional. The TGA source describes SOD1-ALS as a rare ALS form and records regulatory status, not payer access, genetic-testing access, or individual suitability. Confidence/conflicts: High for Australian provisional-approval status; no conflict identified. Availability/reimbursement outside the approving regulator not established.

Canada

riluzole (Mylan-Riluzole and riluzole class context)[6]ApprovedCanadian ALS treatment context for riluzole. · The monograph explicitly states riluzole is not a cure and that symptomatic management remains important. This entry records product-monograph context, not a personalized recommendation or payer status. Confidence/conflicts: Medium-high for Canadian riluzole monograph context; current brand-specific DPD status should be checked for payer implementation. Availability/reimbursement outside the approving regulator not established.
riluzole (Mylan-Riluzole and riluzole class context)[6]ApprovedCanadian ALS treatment context for riluzole. · The monograph explicitly states riluzole is not a cure and that symptomatic management remains important. This entry records product-monograph context, not a personalized recommendation or payer status. Confidence/conflicts: Medium-high for Canadian riluzole monograph context; current brand-specific DPD status should be checked for payer implementation. Availability/reimbursement outside the approving regulator not established.
tofersen (Qalsody)[7]Health Canada approvedmutation in the superoxide dismutase 1 (SOD1) gene; adult SOD1-associated ALS in Canada. · The product monograph states clinical benefit remains to be confirmed and continued approval may depend on confirmatory trials. Health Canada's RDS states the pivotal trial did not adequately demonstrate benefit on the primary endpoint but showed promising evidence and a favourable benefit-risk assessment for a serious condition. Confidence/conflicts: High for conditional Canadian authorization; uncertainty is explicitly recorded in the Health Canada sources. Availability/reimbursement outside the approving regulator not established.
tofersen (Qalsody)[7]Health Canada approvedmutation in the superoxide dismutase 1 (SOD1) gene; adult SOD1-associated ALS in Canada. · The product monograph states clinical benefit remains to be confirmed and continued approval may depend on confirmatory trials. Health Canada's RDS states the pivotal trial did not adequately demonstrate benefit on the primary endpoint but showed promising evidence and a favourable benefit-risk assessment for a serious condition. Confidence/conflicts: High for conditional Canadian authorization; uncertainty is explicitly recorded in the Health Canada sources. Availability/reimbursement outside the approving regulator not established.
tofersen (Qalsody), with background-care context including riluzole and edaravone in CADTH material [8]Health Canada approvedmutation in the superoxide dismutase 1 (SOD1) gene; Canadian reimbursement-with-conditions context for adult SOD1-associated ALS. · CADTH is a reimbursement body, not a prescribing label. It states clinical benefit is of undetermined clinical significance and depends on conditions, including genetic confirmation and jurisdictional implementation. Confidence/conflicts: Medium-high for CADTH reimbursement context; provincial implementation and genetic-testing access remain variable.
tofersen (Qalsody), with background-care context including riluzole and edaravone in CADTH material [8]Health Canada approvedmutation in the superoxide dismutase 1 (SOD1) gene; Canadian reimbursement-with-conditions context for adult SOD1-associated ALS. · CADTH is a reimbursement body, not a prescribing label. It states clinical benefit is of undetermined clinical significance and depends on conditions, including genetic confirmation and jurisdictional implementation. Confidence/conflicts: Medium-high for CADTH reimbursement context; provincial implementation and genetic-testing access remain variable.
tofersen (Qalsody), with background-care context including riluzole and edaravone in CADTH material [8]Health Canada approvedmutation in the superoxide dismutase 1 (SOD1) gene; Canadian reimbursement-with-conditions context for adult SOD1-associated ALS. · CADTH is a reimbursement body, not a prescribing label. It states clinical benefit is of undetermined clinical significance and depends on conditions, including genetic confirmation and jurisdictional implementation. Confidence/conflicts: Medium-high for CADTH reimbursement context; provincial implementation and genetic-testing access remain variable.

출처

DailyMed / U.S. National Library of Medicine — official drug label · official drug label
European Medicines Agency (EMA) — regulator EPAR · regulator EPAR
Pharmaceuticals and Medical Devices Agency / MHLW — regulator review and deliberation report · regulator review and deliberation report
Australian medicine-information repository / Rilutek product information — official product information · official product information
Therapeutic Goods Administration (TGA) — Australian Prescription Medicine Decision Summary · Australian Prescription Medicine Decision Summary
Health Canada / Mylan product monograph repository — official product monograph · official product monograph
Biogen Canada / Health Canada product monograph format — official product monograph with conditions · official product monograph with conditions
CADTH via NCBI Bookshelf — reimbursement recommendation / health technology review · reimbursement recommendation / health technology review

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.