Drugs / Eculizumab
Regulatory milestones approvals, filings & regulatory actions · 8 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed generalized myasthenia gravis 1 milestone | |||||
| Filed | China (NMPA) | Soliris | generalized myasthenia gravis | 2022-11-11 | “the National Medicine Products Administration of China (NMPA) has accepted its supplementary application for Soliris for the treatment of adults with refractory generalised...” astrazeneca.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansions (5) | US (FDA) | SOLIRIS | — | 2011-09-23 – 2025-02-28 | fda.gov ↗ |
| Approved | EU (EMA) | Soliris | — | 2007-06-20 | europa.eu ↗ |
| Approved | US (FDA) | SOLIRIS | — | 2007-03-16 | fda.gov ↗ |
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News releases announcing trial results or a regulatory action · 20
| Date | Issuer | Release |
|---|---|---|
| 2025-06-12 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽 혈액학회(EHA)서 희귀질환 치료제 연구 결과 발표 samsungbioepis.com ↗
삼성바이오에피스는 에피스클리의 장기 안전성을 평가하기 위해 임상 3상 및 연장 치료기간(최대 158주) 동안 투약한 환자들의 중대한 이상반응(SAE: Serious Adverse Event)을 분석했으며, 그 결과 연장 치료기간까지의 투약에서도 초기 치료 결과와 일관된 장기 안전성(long-term safety profile)을 확인했다. |
| 2024-09-29 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽 학회서 희귀질환 치료제 ‘에피스클리’ 연구 결과 발표 samsungbioepis.com ↗
이번 연구 결과에 따르면, 삼성바이오에피스는 에피스클리 임상 시험(3상)을 진행한 PNH 뿐만 아니라 오리지널 의약품이 보유한 aHUS 적응증도 외삽(extrapolation)이 가능함을 확인했다. |
| 2024-07-23 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 희귀질환 치료제 미국서 허가 획득 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)가 미국 식품의약국(FDA: Food and Drug Administration)으로부터 초고가 희귀질환 치료제 '에피스클리®(EPYSQLI®, 프로젝트명 SB12, 성분명 에쿨리주맙)'의 품목허가를 획득했다고 23일 밝혔다. |
| 2024-06-17 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽서 ‘희귀질환 치료제’ 연구 결과 발표 samsungbioepis.com ↗
이번 연구를 통해 에피스클리의 환자 수혈 회피 비율이 오리지널 의약품 대비 임상의학적으로 유의미한 차이가 없음을 확인했으며, 이로써 삼성바이오에피스는 에피스클리와 오리지널 의약품 간 효능(efficacy)의 유사성을 다시 한번 입증했다. |
| 2024-01-22 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 솔리리스 바이오시밀러 '에피스클리(Epysqli™)' 국내 품목 허가 승인 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)는 19일, 식품의약품안전처로부터 혈액학 분야 난치성 희귀질환 치료제 '솔리리스(Soliris)1)'의 바이오시밀러 에피스클리(프로젝트명 SB12, 성분명 에쿨리주맙)의 품목 허가를 승인받았다. |
| 2023-12-08 | Amgen | Results AMGEN HIGHLIGHTS HEMATOLOGY PORTFOLIO AT ASH 2023 amgen.com ↗
Additional Analyses Support Eculizumab (a biosimilar candidate to SOLIRIS ® ) as a Potential Option in Paroxysmal Nocturnal Hemoglobinuria |
| 2023-10-18 | AstraZeneca | Regulatory Soliris approved in China for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) astrazeneca.com ↗
Soliris (eculizumab) has been approved in China for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+). |
| 2023-08-24 | AstraZeneca | Regulatory Soliris approved in Japan for paediatric patients with generalised myasthenia gravis (gMG) astrazeneca.com ↗
Soliris is the first and only targeted therapy approved for the treatment of children and adolescents with gMG in Japan. |
| 2023-07-27 | AstraZeneca | Regulatory Soliris approved in the EU for children and adolescents with refractory generalised myasthenia gravis (gMG) astrazeneca.com ↗
This is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU. |
| 2023-06-26 | AstraZeneca | Regulatory Soliris recommended for approval in the EU by CHMP for children and adolescents with refractory generalised myasthenia gravis (gMG) astrazeneca.com ↗
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on results from the Phase III trial of Soliris in paediatric patients with refractory gMG. |
| 2023-06-13 | AstraZeneca | Regulatory Soliris approved in China for the treatment of adults with refractory generalised myasthenia gravis astrazeneca.com ↗
Soliris (eculizumab) has been approved in China for the treatment of adult patients with refractory generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive. |
| 2023-06-12 | Chugai Pharmaceutical | Results New Data Presented at EHA Show Chugai’s Subcutaneously Administered Crovalimab Achieved Disease Control and was Well-Tolerated in People with Paroxysmal Nocturnal Hemoglobinuria (PNH) chugai-pharm.co.jp ↗
The COMMODORE 2 study demonstrated that subcutaneous crovalimab every four weeks (maintenance dosing) was non-inferior in disease control to intravenous eculizumab every two weeks, with comparable safety, in people new to C5 inhibitors |
| 2023-06-08 | Samsung Bioepis Co., Ltd. | Results 삼성바이오에피스, 유럽 학회서 희귀질환 치료제 추가 분석 결과 공개 samsungbioepis.com ↗
모델링 연구 결과에 따르면, SB12와 오리지널 의약품 간 유효성, 약동학, 약력학 차이가 없는 것으로 확인됐으며, 선행 연구에서 밝혀진 바와 같이 약동학에 영향을 주는 인자는 체중으로 확인됐다. |
| 2023-04-01 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 희귀질환 치료제 유럽 허가 긍정 의견 획득 samsungbioepis.com ↗
삼성바이오에피스(대표이사 고한승 사장)가 1일 유럽 의약품청(EMA: European Medicines Agency) 산하 약물사용 자문위원회(CHMP: Committee for Medicinal Products for Human Use)로부터 '솔리리스(Soliris)1)' 바이오시밀러 '에피스클리(EPYSQLITM, 프로젝트명 SB12, 성분명 에쿨리주맙)'의 판매 허가 긍정 의견(positive opinion)을 획득했다고 밝혔다. |
| 2022-11-11 | AstraZeneca | Regulatory AstraZeneca expands global footprint in rare disease with availability of first Alexion rare disease therapy for patients in China astrazeneca.com ↗
the National Medicine Products Administration of China (NMPA) has accepted its supplementary application for Soliris for the treatment of adults with refractory generalised myasthenia gravis (gMG) in patients who are anti-acetylcholine receptor (AchR) antibody positive |
| 2022-10-24 | Novartis Pharmaceuticals | Results Novartis investigational oral monotherapy iptacopan demonstrates clinically meaningful superiority over anti-C5 treatment in Phase III APPLY-PNH study novartis.com ↗ |
| 2022-09-16 | AstraZeneca | Results Danicopan (ALXN2040) add-on to Ultomiris or Soliris met primary endpoint in ALPHA Phase III trial for patients with paroxysmal nocturnal haemoglobinuria who experience clinically significant extravascular haemolysis astrazeneca.com ↗
Danicopan plus Ultomiris or Soliris demonstrated superiority compared to placebo plus Ultomiris or Soliris for this specific patient population, with statistically significant and clinically meaningful improvements in haemoglobin levels, transfusion avoidance and FACIT Fatigue scores from baseline. |
| 2022-06-10 | Sobi, Inc. | Results New data reinforce robust efficacy and safety profile of Aspaveli/Empaveli (pegcetacoplan) for PNH at the EHA2022 Congress sobi.com ↗
New analyses demonstrated that treatment with Aspaveli/Empaveli resulted in meaningful improvements in quality of life for treatment-naïve patients and suggested the incidence of thrombosis was comparable to eculizumab, a C5 inhibitor. |
| 2021-03-17 | Sobi, Inc. | Results The NEJM publishes phase 3 PEGASUS study results comparing pegcetacoplan to eculizumab for PNH sobi.com ↗ |
| 2020-01-10 | Samsung Bioepis Co., Ltd. | Regulatory 삼성바이오에피스, 중국서 두 번째 임상 개시한다 samsungbioepis.com ↗
삼성바이오에피스는 최근 중국의약품관리국 (NMPA: National Medical Products Administration) 으로부터 SB12 (성분명 에쿨리주맙, 솔리리스 바이오시밀러)의 임상시험 신청서 (CTA: Clinical Trial Application) 를 승인 받았다고 8일 밝혔다. |
All press releases naming this drug 31 releases
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 108 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | eculizumab | “IVMP+Eculizumab arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses (days 1, 8, 15, and 22) in conjunction with IVMP and oral...” NCT07184840 ↗102“Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.” NCT04469465 ↗ “At the time of study start, eculizumab was the only available SoC; eculizumab will be hereafter referred to as SoC.” NCT03439839 ↗ “Investigational arm: eculizumab (900 mg) will be administered intravenously once per week for a total of four doses” NCT06673394 ↗ “Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.” NCT04060264 ↗ “Eculizumab (ECZ) will be administrated intravenously as a 30-minute injection.” NCT02205541 ↗ “Eculizumab (900 mg, 24 hours pre-perfusion) for complement inhibition” NCT07519005 ↗ “International nonproprietary name: eculizumab” NCT04463056 ↗ “Soliris (eculizumab)” NCT04058158 ↗ |
| Known as | BCD-148 | “Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.” NCT04060264 ↗ |
| Known as | Eculizumab (Soliris) | “Eculizumab (Soliris®)” NCT01221181 ↗ |
| Known as | ECZ | “Eculizumab (ECZ) will be administrated intravenously as a 30-minute injection.” NCT02205541 ↗ |
| Known as | Elizaria | “efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland)” NCT04463056 ↗1“At the present time Eculizumab (JSC GENERIUM, Russia) have already been authorized as Elizaria® in Russia.” NCT04679103 ↗ |
| Known as | h5G1.1-mAb | “Eculizumab (h5G1.1-mAb) is a humanized monoclonal antibody that like CD59 inhibits terminal complement.” NCT00130000 ↗ |
| Known as | Soliris | “Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5.” NCT04060264 ↗11“Trial Evaluating Efficacy and Safety of Eculizumab (Soliris) in Patients With COVID-19 Infection” NCT04346797 ↗ “Eculizumab (SB12, EU Sourced Soliris®, and US Sourced Soliris®)” NCT03722329 ↗ “Eculizumab (Soliris) in Covid-19 Infected Patients” NCT04288713 ↗ “Drug: Eculizumab (Soliris®)” NCT07010302 ↗ “Eculizumab (Soliris®)” NCT01410916 ↗ “Eculizumab (Soliris®)” NCT07816237 ↗ |
| Action | Inhibit | “Eculizumab is a humanized monoclonal antibody that like CD59 inhibits terminal complement.” NCT00098280 ↗ |
| Modality | Monoclonal antibody | “Eculizumab is a humanized monoclonal antibody” NCT00098280 ↗ |
| Route | Intravenous | “eculizumab IV over 30 minutes” NCT00112983 ↗ |
| Target | C5 | “the humanized anti-C5 antibody, eculizumab” PMID 21942930 ↗ Sep 2011 |