The European Commission (EC) has approved Alexion Pharmaceuticals’ Soliris (eculizumab) for the treatment of neuromyelitis optica spectrum disorder (NMOSD), extending its current marketing authorisation.
The company announced the new indication for adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease, based on results from the Phase III PREVENT trial.
In the trial, patients were treated with either Soliris or placebo, and it found that at 48 weeks, 98% of patients treated with the drug were relapse free compared to 63% of patients receiving placebo.
Further, of the patients treated solely with Soliris, without receiving other immunosuppressive therapies, 100% were relapse free at 48 weeks compared to 61% in the placebo group.
“In a disease marked by unpredictable relapses that each have the potential for irreversible consequences, such as blindness or the inability to walk, the primary treatment goal is prevention of such attacks. Nearly all patients treated with Soliris were relapse free in the Phase 3 study, demonstrating the potential of SOLIRIS to change the treatment paradigm for this devastating disease,” said John Orloff, executive vice president and head of Research and Development at Alexion.
He continued, “This approval marks an important milestone for the NMOSD community, which now has an approved treatment option that can help protect patients from the next potentially devastating relapse.”
NMOSD is a rare, devastating, complement-mediated disorder of the central nervous system characterised by relapses, also referred to as attacks. Previously known as Devic’s Disease, NMOSD is often confused with other neurological illnesses such as multiple sclerosis (MS), which can lead to delays in diagnosis and treatment with medicines that can worsen disease progression.