A multicenter, randomized, addition to baseline treatment, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of Satralizumab (SA237) in patients with Neuromyelitis Optica (NMO) and NMO Spectrum Disorder (NMOSD)
Status: Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 08 Nov 2019
Price : $35 *
At a glance
- Drugs Satralizumab (Primary)
- Indications Neuromyelitis optica
- Focus Registrational; Therapeutic Use
- Acronyms SAkuraSky
- Sponsors Chugai Pharmaceutical; Roche
- 08 Nov 2019 According to an Chugai Pharmaceutical media release, the company announced that it filed a new drug application(NDA) to the Ministry of Health, Labour and Welfare (MHLW) for satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD). The application is based on the phase III trials SakuraStar and SAkuraSky and will be reviewed under priority review in Japan.
- 30 Oct 2019 According to a Chugai Pharmaceutical media release, European Medicines Agency (EMA) accepted the Marketing Authorisation Application and the US FDA accepted the Biologics License Application (BLA) for satralizumab in adult and adolescent patients with neuromyelitis optica spectrum disorder. EMA granting it Accelerated Assessment. The CHMP recommendation and the FDA decision are expected in 2020. The applications are based on the phase III trial SakuraStar study and SAkuraSky study.
- 13 Sep 2019 According to a Chugai Pharmaceutical media release, based on the data from SakuraStar Study and SAkuraSky Study, the Ministry of Health, Labour and Welfare (MHLW) has granted Orphan Drug Designation for Satralizumab in Neuromyelitis Optica and Neuromyelitis Optica Spectrum Disorder.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History