NDA filed in Japan for satralizumab as NMOSD therapy

A new drug application has been filed with the Japanese Ministry of Health, Labor and Welfare (MHLW) for satralizumab (development code: SA237), an anti-interleukin-6 (IL-6) receptor humanized recycling antibody, for the treatment of neuromyelitis optica spectrum disorder (NMOSD).

Satralizumab received orphan drug designation from the MHLW on September 12, 2019, and the applications will be reviewed under priority review, said the drug’s development Chugai Pharmaceutical (TYO: 4519), which is majority-owned by Swiss pharma giant Roche (ROG: SIX).

“With our proprietary recycling antibody technology, satralizumab is designed to inhibit the signal transduction of IL-6, an inflammatory cytokine that is related to the pathology of NMOSD, by subcutaneous administration once every 4 weeks. In clinical study with the overall population, NMOSD patients including both aquaporin-4 antibodies [AQP4-IgG] seropositive and seronegative patients, clinically significant therapeutic effects were shown either in monotherapy or add-on therapy to baseline treatment,” said Dr Yasushi Ito, Chugai’s executive vice president, co-head of Project & Lifecycle Management Unit, adding: “We believe that the efficacy and safety demonstrated by satralizumab will lead to the provision of a new treatment option to patients. We will work for the approval of satralizumab to provide patients with this new treatment as soon as possible.”