The FDA has approved eculizumab-aeeb (Bkemv) from Amgen Inc as the first interchangeable biosimilar to eculizumab (Soliris) for the treatment of rare diseases paroxysmal nocturnal hemoblobinuria (PNH) and atypical hemolytic uremic syndrome.
“Many rare conditions are life-threatening, and many do not have treatments,” said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, in a news release.1 “The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”
Key Takeaways
- The FDA approved eculizumab-aeeb (Bkemv) as the first interchangeable biosimilar to eculizumab (Soliris) for treating PNH and atypical hemolytic uremic syndrome. This is significant because it can expand treatment options for patients with these rare diseases.
- Eculizumab-aeeb is a monoclonal antibody that targets a specific protein in the immune system's complement cascade. This mechanism helps prevent the breakdown of red blood cells, which is a characteristic of PNH and atypical hemolytic uremic syndrome.
- Eculizumab-aeeb carries a Boxed Warning about an increased risk serious and life-threatening meningococcal infections caused by Neiseeria meningitis.
Eculizumab-aeeb, a monoclonal antibody, targets the complement C5 protein in the immune system’s complement cascade. By binding to C5, eculizumab-aeeb prevents the breakdown of red blood cells. This mechanism helps treat PNH and atypical hemolytic uremic syndrome—both characterized by the breakdown of red cells—which often lead to adverse results such as anemia, thrombosis, pancytopenia, thrombocytopenia, and more.
Eculizumab-aeeb and similar eculizumab products carry a Boxed Warning stating the increased risk of serious and life-threatening meningococcal infections caused by Neiseeria meningitis. To help prevent this risk, the FDA noted that patients should have completed meningococcal vaccination before starting eculizumab-aeeb treatment. Further, the biosimilar is currently only available through a Risk Evaluation and Mitigation Strategy program to ensure the benefits of the medication outweigh its risks.
Eculizumab-aeeb has the same safety warnings and is expected to have the same adverse reactions as eculizumab. Some of the most frequently reported adverse reactions across the PNH randomized trial and atypical hemolytic uremic syndrome single arm prospective trial for eculizumab were headache, the common cold, nausea, diarrhea, abdominal pain.
Eculizamab-aeeb is the 53rd approved biosimilar in the US.
READ MORE: Biosimilars Resource Center
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