Sutimlimab

FDA approves Enjaymo™ (sutimlimab-jome), first treatment for use in patients with cold agglutinin disease

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Friday, February 4, 2022
NASDAQ, Private Securities Litigation Reform Act, Part, Forward-looking statement, Cold agglutinin disease, Intellectual property, Regulation, Medicine, Blood transfusion, Part-time jobs in South Korea, Science, Solution, Indigestion, Research, Acquisition, Annual report, Immune system, SNY, Rupture, Marketing, ULN, Cough, Human, Sutimlimab, Respiratory tract infection, Complement component 1s, Chest pain, SAN, FDA, Patient, AMF, Form 20-F, Safety, Peripheral edema, Anemia, Oxygen, SEC, Autoimmune hemolytic anemia, Degenerative disease, Streptococcus, Hemolysis, Bilirubin, SE, History, CAD, Georgetown Lombardi Comprehensive Cancer Center, Social responsibility, Diarrhea, Weakness, Insurance, Arthritis, Fatigue, Antibody, Arthralgia, COVID-19, Vaccine, Pharmaceutical industry, Health insurance, Sanofi

Enjaymo is the only approved treatment to inhibit red blood cell destruction in CAD and help stop the chain reaction from the start.

Key Points: 
  • Enjaymo is the only approved treatment to inhibit red blood cell destruction in CAD and help stop the chain reaction from the start.
  • For the first time, we have a treatment that targets complement-mediated hemolysis, which is the underlying cause of the red blood cell destruction in many CAD patients.
  • Dosage interruptions due to an adverse reaction occurred in 17 percent (4/24) of patients who received Enjaymo.
  • Following the completion of the 26-week treatment period of CARDINAL (Part A), eligible patients continued to receive Enjaymo in an extension study.

Cold Agglutinin Disease 2020 Market Spotlight - Licensing and Asset Acquisition Deals - ResearchAndMarkets.com

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Friday, July 3, 2020
Health, Pharmaceutical, Acquired hemolytic anemia, Health, Autoimmune diseases, Medical specialties, Antibodies, Cold agglutinin disease, Agglutinin, Sanofi, Clinical trial, Sutimlimab, Cold autoimmune hemolytic anemia

This Market Spotlight report covers the Cold Agglutinin Disease market, comprising disease background and treatment information, key pipeline drugs, clinical trials, probability of success, licensing and acquisition deals, and an epidemiology overview.

Key Points: 
  • This Market Spotlight report covers the Cold Agglutinin Disease market, comprising disease background and treatment information, key pipeline drugs, clinical trials, probability of success, licensing and acquisition deals, and an epidemiology overview.
  • There are only two industry-sponsored drugs in active clinical development for cold agglutinin disease, with one drug each in Phase II and Phase III
    Therapies in development for cold agglutinin disease target the complement pathway.
  • There have been only two licensing and asset acquisition deals involving cold agglutinin disease drugs during 2015-20.
  • Sanofi leads industry sponsors with the highest number of clinical trials for cold agglutinin disease.

FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease

Retrieved on: 
Thursday, May 14, 2020
Autoimmune diseases, Medical specialties, Acquired hemolytic anemia, Life sciences, Health, Cold autoimmune hemolytic anemia, Monoclonal antibodies, Cold agglutinin disease, Sutimlimab, Food and Drug Administration, Biopharmaceutical, Cold sensitive antibodies

FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease

Key Points: 
  • FDA grants priority review of sutimlimab, potential first approved treatment of hemolysis in adult patients with Cold Agglutinin Disease
    PARIS May 14, 2020 - The U.S. Food and Drug Administration (FDA) has granted priority review of Sanofis Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease (CAD).
  • Sutimlimab, an investigational monoclonal antibody, targets the underlying cause of hemolysis in CAD by selectively inhibiting complement C1s.
  • If approved, sutimlimab would be the first and only approved treatment for these patients.
  • If approved, sutimlimab will be the first and only FDA-approved treatment to uniquely address C1-activated hemolysis and help alleviate the chronic disease burden for people with CAD.

Global Cold Agglutinin Disease Market Spotlight 2019: Key Pipeline Drugs, Clinical Trials, Probability of Success, Licensing, Acquisition Deals, and Epidemiology - ResearchAndMarkets.com

Retrieved on: 
Tuesday, November 5, 2019
Health, Other Health, Health, Acquired hemolytic anemia, Autoimmune diseases, Life sciences, Antibodies, Agglutinin, Sanofi, Cold agglutinin disease, Clinical trial, Sutimlimab

This Market Spotlight report covers the Cold Agglutinin Disease market, comprising disease background and treatment information, key pipeline drugs, clinical trials, probability of success, licensing and acquisition deals, and an epidemiology overview.

Key Points: 
  • This Market Spotlight report covers the Cold Agglutinin Disease market, comprising disease background and treatment information, key pipeline drugs, clinical trials, probability of success, licensing and acquisition deals, and an epidemiology overview.
  • There are only two industry-sponsored drugs in active clinical development for cold agglutinin disease, with one drug each in Phase II and Phase III.
  • There have been only two licensing and asset acquisition deals involving cold agglutinin disease drugs during 2014-19.
  • Sanofi leads industry sponsors with the highest number of clinical trials for cold agglutinin disease.