June 29, 2020: “Roche announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved ENSPRYNG® (satralizumab) for the prevention of relapses of neuromyelitis optica spectrum disorder (NMOSD), including NMO, for aquaporin-4 antibody (AQP4-IgG) seropositive adults and children.
ENSPRYNG demonstrated robust efficacy and significantly reduced the risk of relapse across a broad NMOSD patient population in two pivotal Phase III studies, as a monotherapy and as an add-on therapy to baseline immunosuppressant therapy (IST), and is dosed subcutaneously every four weeks.
NMOSD is commonly associated with pathogenic antibodies (AQP4-IgG) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain.
AQP4-IgG antibodies are detectable in the blood serum of around 70-80% of NMOSD patients, and these patients tend to experience a more severe disease course.
Related News: Roche’s satralizumab results in adults and adolescents with neuromyelitis optica spectrum disorder
Although most cases of NMOSD can be confirmed through a diagnostic test, up to 30% of people living with the condition are still frequently misdiagnosed with multiple sclerosis.
“Today’s approval in Japan is the first for ENSPRYNG in Asia, providing a new treatment option to help reduce NMOSD relapses that cause irreversible disability, such as vision loss and paralysis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Japan has a high prevalence of NMOSD in both adults and children, but limited approved treatment options.
ENSPRYNG offers robust efficacy, is well-tolerated, and is the first and only approved therapy targeting the interleukin-6 (IL-6) receptor given subcutaneously every four weeks.”
ENSPRYNG is a humanised monoclonal antibody that targets the IL-6 receptor, believed to play a key role in the inflammation that occurs in people with NMOSD.
ENSPRYNG was designed by Chugai Pharmaceutical Co., a member of the Roche group, using novel antibody recycling technology.
Compared to conventional technology, this allows for longer duration of antibody circulation and maximum inhibition of IL-6 signalling, while minimising safety risks in a chronic disease setting.
People with NMOSD experience unpredictable, severe relapses directly causing cumulative, irreversible neurological damage and disability.
Preventing relapses through early treatment can have a positive impact on preventing disability and is the primary goal for NMOSD disease management.
ENSPRYNG was recently approved in Canada under priority review, as a monotherapy or as an add-on therapy to baseline IST, for the treatment of NMOSD in adult and adolescent patients who are AQP4-IgG seropositive.
In October 2019, the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) accepted the marketing applications for ENSPRYNG for the treatment of NMOSD.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation and the FDA decision are expected in 2020. In April 2020, China’s Centre for Drug Evaluation (CDE) accepted a licensing application for ENSPRYNG.
The approval of ENSPRYNG in Japan is based on data including the two pivotal Phase III studies, SAkuraStar and SAkuraSky, evaluating the efficacy and safety of ENSPRYNG as a monotherapy and as an add-on therapy to baseline IST, respectively.
- In the overall population, a reduction in the risk of relapse was observed in both pivotal studies:
- In SAkuraSky, the risk of relapse was reduced by 62% (HR, 0.38; 95% CI, 0.16–0.88; p=0.0184) with ENSPRYNG, compared to placebo (both treatment arms as an add-on therapy to baseline IST)
- In SAkuraStar, the risk of relapse was reduced by 55% (HR, 0.45; 95% CI, 0.23–0.89; p=0.0184) with ENSPRYNG monotherapy, compared to placebo
- In the pre-specified subgroup of AQP4-IgG seropositive patients, a reduction in the risk of relapse was observed in both pivotal studies:
- In SAkuraSky, the risk of relapse was reduced by 79% (HR, 0.21; 95% CI, 0.06–0.75) with ENSPRYNG, compared to placebo (both treatment arms as an add-on therapy to baseline IST)
- In SAkuraStar, the risk of relapse was reduced by 74% (HR, 0.26; 95% CI, 0.11–0.63) with ENSPRYNG monotherapy, compared to placebo
- Overall, the proportion of patients with serious adverse events was similar between the ENSPRYNG and placebo groups in both studies.
A lower rate of infections (including serious infections) was observed in patients treated with ENSPRYNG compared with the placebo group.
The safety profile in longer term follow up is consistent with the double-blind period.”
https://www.roche.com/media/releases/med-cor-2020-06-29.htm
