Amgen’s Bkemv (Biosimilar, Soliris) Receives the US FDA’s Approval for PNH & aHUS
Shots:
- The US FDA has approved Bkemv (eculizuamb-aeeb), biosimilar to AstraZeneca’s Soliris (eculizumab), for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS)
- The approval was based on the study demonstrating similar efficacy and safety between Bkemv vs Soliris. It will be available only through a restricted program known as the Bkemv Risk Evaluation and Mitigation Strategy (REMS)
- Bkemv is C5 protein targeting mAb resulting in complement system inhibition to prevent the breakdown of RBCs in the bloodstream of patients with PNH and aHUS
Ref: US FDA | Image: Amgen
Related News:- Amgen’s Imdelltra (Tarlatamab-dlle) Receives the US FDA’s Approval to Treat Extensive-Stage Small Cell Lung Cancer
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
