AZN - Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca's Drug | Benzinga
Tuesday, the FDA approved Amgen Inc (NASDAQ:AMGN) Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca Plc’s (NASDAQ:AZN) Soliris (eculizumab) to treat certain rare diseases.
Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:
- The treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.
- The treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
PNH and aHUS are rare diseases characterized by the breakdown of ...