Revcovi (elapegademase-lvlr)

The following drug information is obtained from various newswires, published medical journal articles, and medical conference presentations.

Approval Status:

Approved October 2018

Specific Treatments:

adenosine deaminase severe combined immune deficiency

Therapeutic Areas

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General Information

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase enzyme replacement therapy.

Revcovi is specifically indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.

Revcovi is supplied as a solution for intramuscular injection. The recommended dose schedule is as follows:

• Patients transitioning from Adagen to Revcovi: The starting dose of Revcovi is 0.2 mg/kg weekly. 

• Adagen-naïve patients: The starting dose of Revcovi is 0.4 mg/kg weekly based on ideal body weight, divided into two doses (0.2 mg/kg twice a week).

Clinical Results

FDA Approval

The FDA approval of Revcovi was based on a Phase 3, open-label, multicenter, single-arm, one-way crossover study in 6 patients with ADA-SCID, 8 to 24 years of age, who were receiving therapy with Adagen. The study treatment consisted of three phases: Adagen Lead-in Phase (minimum of 3 weeks), the Revcovi Treatment Phase (weeks 1 through 21), and followed by the Revcovi Maintenance Phase. The starting weekly dose of Revcovi was calculated based on the last Adagen dose received in the study. Weekly Revcovi doses ranged from 0.188 mg/kg to 0.292 mg/k. Efficacy was assessed by 1) Trough dAXP level, 2) Trough plasma ADA activity and 3) Immune status (lymphocyte and B-, T-, and NK-lymphocyte subset counts as well as quantitative immunoglobulin [Ig] concentration [IgG, IgA, IgM]). The data showed treatment with Revcovi increased ADA activity, decreased concentrations of toxic metabolites, and improved total lymphocyte counts.

Side Effects

Adverse effects associated with the use of Revcovi may include, but are not limited to, the following:

• cough

• vomiting

 

Mechanism of Action

Revcovi (elapegademase-lvlr) is a recombinant adenosine deaminase enzyme replacement therapy. Elapegademase-lvlr provides an exogenous source of ADA enzyme that is associated with a decrease in toxic adenosine and deoxyadenosine nucleotides levels as well as an increase in lymphocyte number.

Additional Information

For additional information regarding Revcovi or adenosine deaminase severe combined immune deficiency, please visit https://revcovi.com/