Amgen Secures FDA Nod For Rare-Disease Treatment Biosimilar Based On AstraZeneca's Drug

Tuesday, the FDA approved Amgen Inc AMGN Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca Plc’s 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 red blood cells.

PNH results in anemia (low red blood cells), thrombosis (blood clots), pancytopenia (low counts of red blood cells, white blood cells, and platelets), and dark urine. aHUS results in anemia, thrombocytopenia (low platelets), and kidney failure. 

The monoclonal antibody works by binding to the complement C5 protein, preventing the breakdown of red blood cells in patients with PNH and aHUS.

Bkemv, like Soliris, has a Boxed Warning that states that eculizumab products increase the risk of meningococcal infections caused by Neisseria meningitidis, the bacteria that causes meningitis and other potentially severe infections.

It is mandatory for patients to complete meningococcal vaccination before starting treatment with Bkemv and to be monitored for early signs of infection.

Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy.

Bkemv is the 53rd approved biosimilar in the U.S. The FDA has approved 13 of these as interchangeable biosimilars. 

Read Next: Amgen/AstraZeneca Say Asthma Drug Shows Activity In Another Lung Disease Across Broad Patient Population.

Price Action: AMGN shares are down 0.86% at $297.60 at the last check on Wednesday.

Photo via Shutterstock