New FDA Approval: BKEMV™ (eculizumab-aeeb)
The Food and Drug Administration recently approved BKEMV™. This is the first biosimilar to reference Soliris (eculizumab), for the treatment of two rare diseases: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).
Of note, BKEMV™ is the 53rd approved biosimilar, but the 13th to be deemed interchangeable by the FDA. The interchangeability label could allow pharmacists to exchange BKEMV™ for Soliris without having to get permission from a physician prior, allowing patients to receive their medications in a timelier manner and avoid delays.
Read InpharmD's summary below:
| Drug Name |
BKEMV™ (eculizumab-aeeb) |
| Active Ingredient |
eculizumab |
| Date of Approval |
5/28/24 |
| Manufacturer |
Amgen, Inc. |
| Approval Pathways and Indications |
Approval Pathway: BLA
Indication:
BKEMV™ is a complement inhibitor indicated for:
• The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
• The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy (TMA). |
| Therapeutic Class |
Complement C5 Inhibitor, Monoclonal Antibody |
| Formulation |
Injection for Intravenous Infusion |
| MoA |
Eculizumab-aeeb, the active ingredient in BKEMV™, is a monoclonal antibody that specifically binds to the complement protein C5 with high affinity, thereby inhibiting its cleavage to C5a and C5b and preventing the generation of the terminal complement complex C5b-9.
Eculizumab products inhibit terminal complement-mediated intravascular hemolysis in PNH patients and complement-mediated TMA in patients with aHUS. |
| Dosing and Administration |
Injection: 300 mg/30 mL (10 mg/mL) in a single-dose vial.
Recommended Dosage Regimen – PNH:
For patients 18 years of age and older, BKEMV™ therapy consists of:
• 600 mg weekly for the first 4 weeks, followed by
• 900 mg for the fifth dose 1 week later, then
• 900 mg every 2 weeks thereafter.
Administer BKEMV™ at the recommended dosage regimen time points, or within two days of these time points.
Recommended Dosage Regimen – aHUS:
For patients 18 years of age and older, BKEMV™ therapy consists of:
• 900 mg weekly for the first 4 weeks, followed by
• 1200 mg for the fifth dose 1 week later, then
• 1200 mg every 2 weeks thereafter.
For patients less than 18 years of age, administer BKEMV™ based upon body weight. |
| Administered by self or by HCP |
Administered by HCP |
| Place in Therapy |
BKEMV™ is the first FDA-approved interchangeable biosimilar to SOLIRIS® for treating patients with PNH and aHUS, both considered rare diseases. According to the FDA, a rare disease affects fewer than 200,000 people in the United States.
BKEMV™ is available only through a restricted program—BKEMV™ Risk Evaluation and Mitigation Strategy. Both BKEMV™ and SOLIRIS carry a boxed warning about the increased risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis. Patients should complete meningococcal vaccination before starting either medication and be monitored for early signs and symptoms of these infections.
Of note, BKEMV™ is the 13th biosimilar to be deemed interchangeable (label) by the FDA. The interchangeability label will allow pharmacists to exchange BKEMV™ for Soliris without having to get permission from a physician prior, allowing patients to receive their medications in a more timely manner and avoid delays. Interchangeability labels can also assist in helping pharmacies mitigate supply chain challenges and drug shortages. |
| Expected Market Launch Date |
March 2025 |
| New Molecular Entity (NME) or Existing Formulation |
Existing Formulation |
| Expected Cost |
Unavailable |
| Product Discontinuation |
N/A |
| Clinical Trials |
FDA approval was based on the DAHLIA study, which evaluated the efficacy and safety of BKEMV™ compared with eculizumab in adult participants with PNH (NCT03818607). DAHLIA was a randomized, double-blind, active-controlled Phase 3 study.
The primary analysis for the crossover comparison in the DAHLIA study focused on hemolysis, measured by the time-adjusted area under the effect curve (AUEC) of lactate dehydrogenase (LDH), based on treatment assigned during the 14-week assessments. The time frame for this analysis spanned from Week 13 to Week 27, Week 39 to Week 53, and Week 65 to Week 79. Participants received either BKEMV™ or eculizumab at a dose of 900 mg administered intravenously every 14 ± 2 days, with 40 participants analyzed in each group. The geometric least squares mean concentration over time for BKEMV™ was 1445.76 U·day/L/week (95% CI: 1295.63 to 1613.28), while for eculizumab it was 1473.44 U·day/L/week (95% CI: 1321.86 to 1642.41). The 90% confidence interval for the ratio of the geometric least squares means between BKEMV™ and eculizumab ranged from 0.9403 to 1.0239, indicating that the pharmacokinetic profiles of the two treatments were very similar and suggested bioequivalence. |
| Sources |
1. Formulary Watch. (2024, May 29). FDA approves first interchangeable biosimilar of Soliris. https://www.formularywatch.com/view/fda-approves-first-interchangeable-biosimilar-of-soliris
2. Haigney, S. (2024, May 29). FDA approves interchangeable biosimilar to Soliris. BioPharm International. https://www.biopharminternational.com/view/fda-approves-interchangeable-biosimilar-to-soliris |
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