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Revcovi (ELAPEGADEMASE)
Revcovi works by replacing the deficient enzyme adenosine deaminase, allowing the body to break down toxic substances.
Revcovi, developed by Leadiant Biosci Inc, is an enzyme replacement therapy for adenosine deaminase severe combined immune deficiency (ADA-SCID) currently on the market. Its key strength lies in its mechanism of action, which directly addresses the enzyme deficiency, potentially offering a more targeted treatment compared to off-patent alternatives. The primary risk is the competition from other same-class drugs, including pegademase, which has been on the market since 1990, and plerixafor, which is now off-patent and available as generics.
At a glance
| Generic name | ELAPEGADEMASE |
|---|---|
| Sponsor | Leadiant Biosci Inc |
| Modality | Enzyme |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
SCID associated with deficiency of ADA enzyme is rare, inherited, and often fatal disease. ADA enzyme is involved in purine metabolism, catalyzing the irreversible hydrolytic deamination of adenosine or deoxyadenosine to inosine or deoxyinosine, respectively, as well as several naturally occurring methylated adenosine compounds. Maintaining low level of 2-deoxyadenosine and adenosine is crucial for proper number and function of immune cells as well as decreasing the frequency of opportunistic infections. Elevated adenosine levels, as occurring in ADA deficiency, contribute to apoptosis and block in the differentiation of thymocytes, causing severe T-lymphopenia.Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number [see Clinical Studies (14)].
Approved indications
- Adenosine deaminase severe combined immune deficiency (ADA-SCID)
Common side effects
- Cough
- Vomiting
- Respiratory infections
- Neutropenia
- Hemolytic anemia
- Thrombocythemia
- Thrombocytopenia
- Injection site erythema
- Urticaria
- Lymphomas
- Abdominal pain upper
- Arthralgia
Key clinical trials
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Revcovi CI brief — competitive landscape report
- Revcovi updates RSS · CI watch RSS
- Leadiant Biosci Inc portfolio CI