New 4-year data show Enspryng significantly reduces debilitating relapses in people with AQP4-IgG seropositive neuromyelitis optica spectrum disorder.
The data show Enspryng has a favorable benefit-risk profile and is effective in reducing relapses over four years of treatment in people with anti-aquaporin-4 antibody (AQP4-IgG) seropositive NMOSD , a rare debilitating disease that affects the central nervous system. Efficacy and safety results from the open-label extension (OLE) periods of the SAkuraStar and SAkuraSky studies, in addition to the design of SAkuraBONSAI, a new study in people with AQP4-IgG seropositive NMOSD who are treatment-naïve, or where prior rituximab (or biosimilar) treatment has failed, will be presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
The pivotal SAkuraStar and SAkuraSky four year OLE data found that 73% and 71% of people with AQP4-IgG seropositive NMOSD treated with Enspryng remained relapse-free after 192 weeks (3.7 years), respectively, and 90% and 91% remained free from severe relapse. These results demonstrate that the robust efficacy observed in the studies’ double-blind periods is sustained longer-term for Enspryng as both a monotherapy and in combination with immunosuppressive therapy.
The data also demonstrate a favorable safety and tolerability profile for Enspryng in the overall Enspryng treatment period of up to seven years, comparable to the double-blind treatment periods in both SAkuraStar and SAkuraSky studies. Rates of adverse events and serious adverse events during the overall treatment periods were consistent with Enspryng and placebo in the double-blind periods. The most common adverse reactions observed were: headache, arthralgia, white blood cell count decrease, hyperlipidemia, and injection-related reactions. No new safety signals were observed.
Genentech is also initiating SAkuraBONSAI, a multicenter, Phase IIIb, international study, to further evaluate disease activity and progression using comprehensive imaging, biomarker and clinical assessments in NMOSD populations where further research is warranted. People with AQP4-IgG seropositive NMOSD, who are treatment-naïve or where prior rituximab (or biosimilar) treatment has failed, will be administered Enspryng monotherapy for two years and evaluated using clinical measures such as magnetic resonance imaging, optical coherence tomography and biomarkers of blood and cerebrospinal fluid.
Enspryng is the first and only NMOSD treatment administered subcutaneously every four weeks for adults living with AQP4-IgG seropositive NMOSD, allowing for home-dosing and increasing flexibility and convenience for people with NMOSD. Enspryng is approved in 58 countries, including the United States, Canada, Japan, South Korea and the European Union and applications are under review in additional countries.
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