Drugs / sutimlimab
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed cold agglutinin disease 5 milestones | |||||
| Filed | US (FDA) | — | cold agglutinin disease | 2021-10-28 | “The FDA accepted the resubmission of the Biologics License Application (BLA) for sutimlimab” sanofi.com ↗ |
| Rejected (CRL) | US (FDA) | — | cold agglutinin disease | 2020-11-14 | “The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab” sanofi.com ↗ |
| Filed | US (FDA) | — | cold agglutinin disease | 2020-05-14 | “The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab” sanofi.com ↗ |
| Filed | Japan (PMDA) | — | cold agglutinin disease | — | “Outside of the U.S., sutimlimab has been submitted to regulatory authorities in Europe and Japan and reviews are ongoing.” sanofi.com ↗ |
| Filed | EU (EMA) | — | cold agglutinin disease | — | “Outside of the U.S., sutimlimab has been submitted to regulatory authorities in Europe and Japan and reviews are ongoing.” sanofi.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | EU (EMA) | Enjaymo | — | 2022-11-15 | europa.eu ↗ |
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03275454 | Aug 2017 → Feb 2021 | autoimmune thrombocytopenic purpura | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 1 | NCT02502903 | Jul 2015 → Mar 2021 | autoimmune hemolytic anemia, warm type, bullous pemphigoid, cold agglutinin disease, end stage renal failure | Bioverativ, a Sanofi company | Completed | No outcome recorded |
| Phase 33 trials · 2 met primary | ||||||
| Phase 3 | NCT05132127 | Nov 2021 → Nov 2022 | cold agglutinin disease | Sanofi | Completed | No outcome recorded |
| Phase 3 | NCT03347422 | Mar 2018 → Dec 2021 | cold agglutinin disease | Bioverativ, a Sanofi company | Completed | Met primary |
| Phase 3 | NCT03347396 | Mar 2018 → Oct 2021 | cold agglutinin disease | Bioverativ, a Sanofi company | Completed | Met primary |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2022-11-17 | Sanofi | Regulatory Press Release: European Commission approves Enjaymo® (sutimlimab) for treatment of hemolytic anemia in adult patients with cold agglutinin disease sanofi.com ↗
European Commission approves Enjaymo ® ( sutimlimab ) for treatment of hemolytic anemia in adult patients with cold agglutinin disease |
| 2022-09-16 | Sanofi | Regulatory Media Update: CHMP recommends approval of Enjaymo™ (sutimlimab), first and only approved treatment for hemolytic anemia in adult patients with cold agglutinin disease sanofi.com ↗
CHMP recommends approval of Enjaymo™ (sutimlimab), first and only approved treatment for hemolytic anemia in adult patients with cold agglutinin disease |
| 2022-06-10 | Sanofi | Results Media Update: Sanofi, a leader in immune-mediated rare blood disorders, to present latest data at EHA 2022 sanofi.com ↗
Follow-up data support the CARDINAL Part A findings, showing that Enjaymo™ maintained mean hemoglobin >11g/dL and achieved sustained normalization of mean bilirubin in patients after two years, demonstrating the efficacy and safety profile for the therapy in CAD (abstract #S285). |
| 2022-02-04 | Sanofi | Regulatory FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has approved Enjaymo™ (sutimlimab-jome) to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease (CAD). |
| 2021-06-11 | Sanofi | Results New pivotal data at EHA 2021 reinforces sutimlimab as a first-in-class investigational C1s inhibitor with the potential to be the first approved treatment for hemolysis in people with CAD, a serious and chronic autoimmune hemolytic anemia sanofi.com ↗
The data demonstrated treatment with sutimlimab resulted in rapid and sustained inhibition of C1-activated hemolysis in people with CAD, noted within one week of treatment, and clinically significant improvements in hemoglobin and fatigue when compared to placebo during the course of the study. |
| 2021-04-07 | Sanofi | Results Positive results from the sutimlimab pivotal trial for people with cold agglutinin disease published in New England Journal of Medicine sanofi.com ↗
The New England Journal of Medicine (NEJM) today published the final results of Part A of the pivotal Phase 3 CARDINAL open label, single-arm study evaluating the safety and efficacy of sutimlimab for 26 weeks in people with primary cold agglutinin disease (CAD). |
| 2021-02-05 | Sanofi | Regulatory Sanofi delivered close to double-digit Q4 2020 business EPS(1) growth at CER sanofi.com ↗ |
| 2020-11-14 | Sanofi | Regulatory FDA issues Complete Response Letter for sutimlimab, an investigational treatment for hemolysis in adults with cold agglutinin disease sanofi.com ↗
The U.S. Food and Drug Administration issued a Complete Response Letter (CRL) regarding the Biologics License Application (BLA) for sutimlimab, an investigational monoclonal antibody for the treatment of hemolysis in adults with cold agglutinin disease. |
| 2020-05-14 | Sanofi | Regulatory FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease sanofi.com ↗
The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofi’s Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). |
All press releases naming this drug 11 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 7 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sutimlimab | “Sutimlimab, a first-in-class humanized monoclonal anti-C1s IgG4 antibody, selectively inhibits the classical pathway.” PMID 35973190 ↗ Mar 2023 |
| Known as | BIVV009 | “received sutimlimab (BIVV009) 6.5 grams as intravenous (IV) infusion on Day 0, Day 7, Day 21 and thereafter every 2 weeks (maximum duration: 49 weeks) in the current study.” NCT05132127 ↗3“The study drug name is changed to BIVV009 with final version Final 15.0 of the clinical study protocol.” NCT02502903 ↗ “sutimlimab (BIVV009)” NCT03347422 ↗ |
| Known as | Enjaymo | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297832 ↗ |
| Known as | Sutimlimab jome | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297832 ↗ |
| Known as | TNT-009 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297832 ↗ |
| Action | Inhibit | “BIVV009 profoundly inhibited overall and DSA-triggered CP activation in serum.” PMID 28980446 ↗ Oct 2017 |
| Modality | Monoclonal antibody | “Sutimlimab, a first-in-class humanized monoclonal anti-C1s IgG4 antibody” PMID 35973190 ↗ Mar 2023 |
| Route | Intravenous | “BIVV009 by IV infusion” NCT02502903 ↗ |
| Target | C1S | “Sutimlimab, a first-in-class humanized monoclonal anti-C1s IgG4 antibody” PMID 35973190 ↗ Mar 2023 |