Drug updated on 9/4/2024
Dosage Form | Injection (intramuscular; 2.4 mg/1.5 mL [1.6 mg/mL]) |
Drug Class | Recombinant 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
- 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 Title | Year | Source |
---|---|---|
Revcovi (elapegademase-lvlr) Prescribing Information. | 2020 | Chiesi USA, Inc. Cary, NC |
Randomized Controlled Trials
Document Title | Sex Distribution | Year | Source |
---|---|---|---|
Safety and efficacy of elapegademase in patients with adenosine deaminase deficiency: a multicenter, open-label, single-arm, phase 3, and postmarketing clinical study. | 4Subjects F: 50% M: 50% | 2023 | Immunity, Inflammation and Disease |
Sex Distribution:
F:50%
M:50%
4Subjects
Year:
2023
Source:Immunity, Inflammation and Disease