Enspryng reduces relapse in NMOSD subgroup
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Chugai Pharmaceutical Co. released data showing Enspryng had a favorable benefit-risk profile and effectively reduced relapses over 4 years of treatment among people with a form of neuromyelitis optica spectrum disorder.
The treatment is a pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody. Data on its efficacy and safety from open-label extension periods of two studies, as well as results from an additional study, was presented at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
“The data show that the efficacy and safety of Enspryng [satralizumab, Chugai], which inhibits IL-6 signaling, are sustained over time,” Osamu Okuda, president and CEO of Chugai, said in a press release. “[Neuromyelitis optica spectrum disorder (NMOSD)] is a lifelong disease where prevention of relapse is crucial, and its treatment often lasts several years.
“We believe that these data provide important evidence to help patients and health care professionals continue treatment with Enspryng with confidence,” Okuda added.
Data from the pivotal phase 3 SAkuraStar and SAkuraSky showed 73% and 71% of participants with anti-aquaporin-4 antibody (AQP4-IgG)-seropositive NMOSD who received satralizumab treatment were relapse free after 3.7 years, respectively. Further, 90% and 91% did not experience severe relapse. These results showed that the efficacy seen in the double-blind study periods was sustained longer term for the treatment as both a monotherapy and combined with immunosuppressive therapy.
According to the release, the data indicated that the safety profile of satralizumab in the overall treatment period of up to 7 years was comparable to the double-blind treatment periods in the SAkuraStar and SAkuraSky studies. The overall treatment periods had consistent rates of adverse events and serious adverse events compared with satralizumab and placebo in the double-blind treatment periods. Researchers reported no new safety signals.
Roche plans to initiate the multicenter, phase 3b, international SAkuraBONSAI study, which will further examine disease activity and progression via comprehensive imaging, biomarker and clinical assessments among populations with NMOSD where additional research is necessary.
“We will continue providing information on the appropriate use of this drug so that Enspryng may further contribute to the treatment of NMOSD,” Okuda said in the release.