FDA Approved: BKEMV — Supplemental Application (Amgen Inc)

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Summary

The FDA approved a supplemental application for BKEMV (eculizumab-aeeB) from Amgen, updating its labeling and indications for this eculizumab biosimilar.

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Diseases / indications

• Atypical Hemolytic Uremic Syndrome
• Generalized Myasthenia Gravis
• Neuromyelitis Optica Spectrum Disorder
• Paroxysmal Nocturnal Hemoglobinuria

Drugs mentioned

• BKEMV (eculizumab-aeeB)

Snippet

SUPPL AP for BKEMV (ECULIZUMAB-AEEB)