The efficacy of satelizumab (Anshiping)

The U.S. Food and Drug Administration (FDA) has approved Satralizumab for the treatment of adults with neuromyelitis optica spectrum disorder (NMOSD) who are positive for anti-aquaporin 4 or AQP4 antibodies. Neuromyelitis optica spectrum disorder is a rare autoimmune disease of the central nervous system that primarily affects the optic nerve and spinal cord. Satelizumab is the third approved treatment for the disease.

Two 96-week clinical studiesproved the efficacy and safety of satelizumab in the treatment of NMOSD. The first study included 95 adult patients; 64 of these patients had anti-AQP4 antibodies (anti-AQP4 positive). In this study, treatment with satelizumab reduced the number of NMOSD relapses in anti-AQP4-positive patients by 74% compared with placebo treatment (inactive treatment). The second study included 76 adult patients; 52 of these patients were anti-AQP4 positive. In the second study, treatment with satelizumab reduced the number of relapses in anti-AQP4-positive patients by 78% compared with placebo treatment. In both trials, there was no evidence of benefit in patients who were negative for anti-AQP4 antibodies.

The original drug satlizumab has been launched in China, sold under the brand name Anshiping, and is included in medical insurance. Only patients who meet the indications can be reimbursed. The specification is120mg (1ml) per box The price may be more than RMB 10,000, which is still relatively expensive; the price of each box of the original drug Saterizumab sold overseas is more than $10,000 (the price may fluctuate due to the exchange rate). The ingredients of the original drug sold domestically and abroad are basically the same. There are currently no generic versions of satlizumab available on the market.