A Phase III, Open-label, Extension Trial of ECU-NMO-301 to Evaluate the Safety and Efficacy of Eculizumab in Patients With Relapsing Neuromyelitis Optica (NMO)
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 06 Oct 2019
Price : $35 *
At a glance
- Drugs Eculizumab (Primary)
- Indications Neuromyelitis optica
- Focus Adverse reactions
- Sponsors Alexion Pharmaceuticals
- 27 Aug 2019 According to an Alexion Pharmaceuticals media release, the European Commission (EC) has approved the extension of the current marketing authorization of SOLIRIS(eculizumab) to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody-positive with a relapsing course of the disease, based on comprehensive results of this trial and PREVENT trial (CTP- 238377).
- 24 Jul 2019 According to an Alexion Pharmaceuticals media release, the European Medicines Agency Committee for Medicinal Products for Human Use has issued a positive opinion to extend the current marketing authorization of SOLIRIS to include the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients. The European Commission will review the CHMP opinion and the final decision is anticipated within 2 months.
- 31 Aug 2018 Biomarkers information updated