Handok’s Soliris expands indication to NMOSD

Handok said Friday that the Ministry of Food and Drug Safety has approved an expanded indication for Soliris (ingredient: eculizumab) to treat neuromyelitis optica spectrum disorder (NMOSD) patients with antibodies against anti-aquaporin-4.

Handok’s Soliris gained an expanded indication as a treatment for neuromyelitis optica spectrum disorder (NMOSD). (Handok)

The expanded indication provides a new therapeutic option for NMOSD patients who continue to experience recurrence despite receiving steroids or immunosuppressive therapy.

NMOSD is a rare autoimmune disease of the central nervous system that primarily attacks the optic nerves and spinal cord, leading to blindness and paralysis. The most common symptoms of NMO are optic neuritis and transverse myelitis, which can lead to mobility impairment, including paralysis.

About 25 to 60 percent of NMOSD patients undergo continuous relapses with poor prognoses even after receiving immunosuppressant therapy. The disorder can cause brain, optic nerve, and spinal cord damage and lead to long-term disability.

According to the phase 3 PREVENT trial published in the New England Journal of Medicine in 2019, about 98 percent of NMOSD patients with anti-aquaporin-4 antibodies who received Soliris were relapse-free by the 48th week.

In comparison, only 63 percent of subjects in the placebo group were relapse-free. At week 144, patients treated with Soliris were 96 percent relapse-free, while the placebo group's comparable rate fell to 45 percent.

Soliris has indications for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome. The original developer is Alexion Pharmaceuticals, and its partner Handok has been distributing Soliris in Korea.

Handok has introduced innovative products for rare diseases in recent years, developing business in the area of rare diseases.

Among other such drugs are Tracleer, Opsumit, and Uptravi for pulmonary hypertension, Defitelio for veno-occlusive disease, and Galafold for Fabry disease.