Managed Healthcare Executive July 22, 2024
Formulary Watch

Epysqli is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.

The FDA has approved another biosimilar of Soliris (eculizumab). Samsung Bioepis’ Epysqli (eculizumab-aagh) has been approved to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS).

PNH is an ultra-rare blood disorder that is characterized by the destruction of red blood cells. PNH occurs when the complement system — a part of the body’s immune system — over-responds, leading the body to attack its own red blood cells. Atypical hemolytic uremic syndrome is a rare genetic disease in which tiny blood clots form in blood vessels and block blood flow. It can lead to...

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Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
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