FDA approves Soliris, first therapy for rare neurological disease

In a historic decision, the US Food and Drug Administration approved Soliris (eculizumab) for a rare neurological disorder.

Developed and marketed by US biotech Alexion Pharmaceuticals (Nasdaq: ALXN), Soliris is the first and only FDA approved treatment for neuromyelitis optica spectrum disorder (NMOSD) in adults who have tested positive for anti-aquaporin-4 (AQP4) auto-antibodies, which accounts for approximately three quarters of all patients with NMOSD.

NMOSD is a rare, severe, medical condition that attacks the central nervous system (CNS) without warning. Attacks, referred to as relapses, can cause irreversible damage to the brain and other functions of the body, which could lead to long-term disability. Soliris has the potential to reduce the risk of future attacks caused by this rare neurological disease.