REVCOVI
REVCOVI (elapegademase-lvlr) is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID). The therapy is approved for use in both pediatric and adult patient populations. It serves as an exogenous enzyme replacement to manage a rare, inherited metabolic disorder that affects the development and function of immune cells.
How REVCOVI Works
The medication provides an exogenous source of the ADA enzyme to facilitate the metabolism of adenosine and deoxyadenosine into inosine and deoxyinosine. In patients with ADA deficiency, the accumulation of these compounds leads to the death of thymocytes and a failure in immune cell differentiation. By lowering these toxic nucleotide levels, the drug helps increase lymphocyte counts and supports proper immune system function.
Details
- Status
- Prescription
- First Approved
- 2018-10-05
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
REVCOVI Approval History
What REVCOVI Treats
1 indicationsREVCOVI is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Adenosine Deaminase Severe Combined Immunodeficiency
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REVCOVI FDA Label Details
ProIndications & Usage
FDA Label (PDF)REVCOVI is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients. REVCOVI is a recombinant adenosine deaminase indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.