Elapegademase-lvlr

(Revcovi®)

Elapegademase-lvlr

Drug updated on 9/4/2024

Dosage FormInjection (intramuscular; 2.4 mg/1.5 mL [1.6 mg/mL])
Drug ClassRecombinant adenosine deaminases
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of adenosine deaminase severe combined immunity deficiency (ADA-SCID) in pediatric and adult patients.

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Summary
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  • Revcovi (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immunity deficiency (ADA-SCID) in pediatric and adult patients.
  • This summary is based on the review of one randomized controlled trial(s). [1]
  • Biochemical Markers: All four patients in the study achieved undetectable levels of deoxyadenosine nucleotide (dAXP), and sufficient enzyme activity was maintained across all patients, as evidenced by trough serum ADA activity levels.
  • Immune System Markers: The study reported increases in T and B cell numbers for all patients, along with slightly elevated and maintained IgM and IgA immunoglobulin levels.
  • Comparison to Other Drugs: Elapegademase demonstrated comparable efficacy to pegademase in enzyme-replacement therapy for ADA deficiency, with no significant differences in effectiveness among different population types or subgroups.
  • Serious adverse events occurred in three patients, but these events were assessed as unrelated to elapegademase.
  • One infant patient died of pneumonia caused by cytomegalovirus infection, which was not attributed to elapegademase. No drug-related adverse events or significant safety concerns were reported.

Product Monograph / Prescribing Information

Document TitleYearSource
Revcovi (elapegademase-lvlr) Prescribing Information.2020Chiesi USA, Inc. Cary, NC

Randomized Controlled Trials