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- Enjaymo (sutimlimab-jome) FDA Approval History - Drugs. com
Enjaymo FDA Approval History Last updated by Judith Stewart, BPharm on March 21, 2022 FDA Approved: Yes (First approved February 4, 2022) Brand name: Enjaymo Generic name: sutimlimab-jome Dosage form: Injection Company: Sanofi Treatment for: Cold Agglutinin Disease Enjaymo (sutimlimab-jome) is a classical complement inhibitor indicated to decrease the need for red blood cell (RBC
- ENJAYMO® (sutimlimab-jome) | Cold Agglutinin Disease Treatment
ENJAYMO is the first and only FDA-approved treatment for people with cold agglutinin disease (CAD) to help decrease the need for red blood cell transfusion For U S Residents Only ENJAYMO Patient Solutions (1-833-223-2428) Prescribing Info Medication Guide HCP Website
- FDA Approves Enjaymo® after pivotal study results | Sanofi
Enjaymo is the only approved treatment to decrease the need for red blood cell transfusion due to hemolysis, the destruction of red blood cells, in adults with cold agglutinin disease (CAD) Enjaymo addresses a serious and chronic unmet medical need for adults living with CAD, a rare blood disorder; Paris, February 4, 2022 The U S Food and
- FDA Approves Enjaymo for Treatment of Cold Agglutinin Disease
The approval of Enjaymo in the United States is based on positive results from the 26-week open-label, single-arm pivotal phase 3 CARDINAL study for individuals with CAD who have a recent history of blood transfusion In the study, Enjaymo met its primary efficacy endpoint, whichwas a composite endpoint defined as the proportion of individuals
- Press Room - Sanofi US News
Enjaymo is currently the only approved treatment of hemolysis for CAD It is a first-in-class humanized monoclonal antibody that is designed to selectively target and inhibit the classical complement pathway specific serine protease, C1s By blocking C1s of the classical complement pathway, Enjaymo inhibits C1-activated hemolysis in CAD to
- Drug Trials Snapshots: ENJAYMO | FDA
ENJAYMO is a prescription drug that decreases the need for red blood cell (RBC) The FDA approved ENJAYMO based on evidence from one clinical trial of 24 patients with CAD The trial was
- Enjaymo Becomes 1st Treatment Approved in US for Adults With CAD
Enjaymo, which works by preventing hemolysis, is the first and only FDA-approved therapy for CAD, according to its developer, Sanofi “Until now, people living with cold agglutinin disease haven’t had an approved treatment option to manage the constant destruction of red blood cells,” Bill Sibold, Sanofi’s executive vice president and head of specialty care, said in a press release
- FDA Approval Updates Enjaymo Indication for Cold Agglutinin Disease
Enjaymo is an immunoglobulin G subclass 4 monoclonal antibody The Food and Drug Administration (FDA) has expanded the approval of Enjaymo ® (sutimlimab-jome) for the treatment of hemolysis in
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