Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 37 |
| INN | Sutimlimab |
| Status | Approved |
| Drug code(s) | BIVV-009, TNT009 |
| Brand name | Enjaymo |
| mAb sequence source | mAb chimeric/humanized |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG4 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | None |
| Target(s) | Complement C1s |
| Indications of clinical studies | Idiopathic Thrombocytopenic Purpura, Chronic immune thrombocytopenia, Complement-mediated disorders |
| Primary therapeutic area | Cardiovascular / hemostasis disorders |
| Most advanced stage of development (global) | Approved EU, US, Japan |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | June 15, 2015 |
| Start of Phase 2 | |
| Start of Phase 3 | December 15, 2017 |
| Date BLA/NDA submitted to FDA | August 05, 2021 |
| Year of first approval (global) | 2022 |
| Date of first US approval | February 04, 2022 |
| INN, US product name | Sutimlimab, sutimlimab-jome |
| US or EU approved indications | Administered to decrease the need for red blood cell transfusion due to hemolysis in adults with cold agglutinin disease. |
| Company | Sanofi |
| Licensee/Partner | None |
| Comments about company or candidate | Approved in the EU in Nov 2022. June 2021: Results of a second late-stage trial assessing Sanofi's sutimlimab as a treatment for the chronic autoimmune hemolytic anemia cold agglutinin disease met the study's primary endpoint, which will support a plan to seek regulatory approval for the drug in the European Union. The company also plans to resubmit its application for sutimlimab with the FDA in the second half of 2021. Nov 2020: The U.S. Food and Drug Administration (FDA) stunned Sanofi with a Complete Response Letter (CRL) for its blood cancer treatment sutimlimab. The medication was expected to be the first treatment approved for the treatment of cold agglutinin disease (CAD). May 14, 2020: Sanofi announced that the U.S. Food and Drug Administration (FDA) has granted priority review of its Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD). The PDUFA date is November 13, 2020. Submission of BLA divulged in Q1 Earnings call on April 24, 2020. Phase 3 data expected in 2020. Bioverativ disclosed that dosing is underway for its late-stage trial to evaluate the efficacy of its candidate BIVV009 in patients with a rare autoimmune disorder called cold agglutinin disease. The trial involves two parallel studies, CARDINAL, with an estimated primary completion date of June 2019, and CADENZA, which is slated for completion by December 2019. January 22, 2018 - Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing an equity value of approximately $11.6 billion (on a fully diluted basis). The transaction was unanimously approved by both the Sanofi and Bioverativ Boards of Directors. NCT03275454 Phase 1 in Idiopathic Thrombocytopenic Purpura recruiting as of Aug 2017. USA orphan designation for treatment of bullous pemphigoid and Cold Agglutinin Disease; US breakthrough therapy designation for treatment of hemolysis in patients with primary CAD. EU orphan for Autoimmune haemolytic anaemia including cold agglutinin disease. Bioverativ is a spin off of Biogen; agreed to acquire True North in May 2017. NCT02502903 Phase 1 started July 13, 2015, Phase 1 in chronic immune thrombocytopenia started in Aug 2017. |
| Full address of company | Paris, France Europe France https://www.sanofi.us/en/contact-us |
Humanized mAb with target in the complement pathway. Intended for rare diseases in the hematologic, renal and neurological areas. Humanized and chimeric according to WHO Drug Information Vol 31, No. 4, 2017; proposed INN list 118. S228P; L235E. Hinge stabilized; reduced effector functions.
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |