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...

Today's Sponsors

LEK
ZeOmega

Today's Sponsor

LEK

 
Topics: Biotechnology, FDA, Govt Agencies, Pharma / Biotech
FDA warns GLP-1 compounder over safety rules
GLP-1 drug approvals: A breakdown
Rethinking FDA’s Accelerated Approval Pathway: New Draft Guidances and Implications for Drug Companies
FDA approves Novo Nordisk's Ozempic to treat chronic kidney disease in those with diabetes, expanding its use
Certainty vs. speed: How do patients feel about the tradeoff for new cancer drugs?

Share This Article