Enspryng

ENSPRYNG® (Satralizumab), pre-filled syringe 120 mg (120 mg Satralizumab / 1 ml solution for injection) for subcutaneous injection
Swissmedic marketing authorization number: 67617
Swissmedic marketing authorization date: 13/07/2020

Marketing authorisation studies (2):

1. SAkuraStar (BN40900, SA-309JG)

Indication: Neuromyelitis Optica Spectrum Disorders (NMOSD)

Phase: III

Summary: Randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and safety of Enspryng as Monotherapy in comparison with placebo in adult (aged ≥18 to ≤74) Aquaporin-4-IgG seropositive and seronegative NMO and NMOSD patients.

Sponsor: F. Hoffmann-La Roche Ltd

2. SAkuraSky (BN40898, SA-307JG)

Indication: NMOSD

Phase: III

Summary: Randomized, double-blind, multicenter, placebo-controlled study to evaluate the efficacy and safety of Enspryng in combination with immunosuppressive therapy (IST) in comparison with placebo and IST in adult and adolescent (aged ≥12 to ≤74) Aquaporin-4-IgG seropositive and seronegative NMO and NMOSD patients.

Sponsor: F. Hoffmann-La Roche Ltd


Publication of the results of clinical trials
The information given above and the links to the clinical data fulfil the requirements of Articles 71-73 of the Ordinance on Therapeutic Products (Therapeutic Products Ordinance, TPO) and amend the information published in association with the Swiss marketing authorization for Enspryng. Articles 71-73 TPO apply to all medicinal products that were submitted as of January 2019 and were granted marketing authorization by Swissmedic. The published data will help doctors and other healthcare service providers to take well-informed decisions on treatment and allow researchers to more easily build on the research carried out by Roche and its partners, as well as that carried out by other researchers, to ensure continued scientific progress.