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• Enspryng is a new treatment approved in the EU for both adults and adolescents with AQP4-IgG seropositive NMOSD. It is the first treatment approved in the EU for adolescents aged 12 and over with NMOSD.

• Enspryng is the first approved drug to use Chugai's proprietary recycled antibody technology. It can be self-administered subcutaneously every four weeks at home.

• Enspryng significantly reduced the risk of relapse in people with AQP4-IgG-seropositive NMOSD in two global phase III studies.

• The medicine is approved in 54 countries including Japan, the United States and the EU.

Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced today that Roche has received marketing approval from the European Commission for the pH-dependent humanized monoclonal anti-IL-6 receptor antibody Enspryng ®(Satralizumab). This antibody was developed by Chugai as the first subcutaneous treatment option for adults and adolescents from the age of 12 who suffer from a neuromyelitis optica spectrum disorder (NMOSD) seropositive to antibodies against aquaporin-4 (AQP4-IgG). and live as monotherapy or in combination with immunosuppressive therapy (IST). Enspryng is the first treatment approved in the EU for adolescents aged 12 and over with NMOSD.

"We are very pleased that Enspryng is now approved in the EU as the first subcutaneous treatment for people with AQP4-IgG seropositive NMOSD, with the option of home treatment," said Chugais President and CEO Dr. Osamu Okuda. “Enspryng is the first approved therapeutic antibody to use our proprietary recycled antibody technology. We are confident that Enspryng will make a significant contribution to improving the treatment of people with NMOSD by integrating it into their everyday lives. "

The effectiveness and safety of Enspryng have been studied in large clinical studies representative of the real population of people with NMOSD, including those who have had a single attack of NMOSD and adolescents. The approval by the European Commission is based on the results of two global phase III clinical studies in people with NMOSD: the SAkuraSky study (NCT02028884) and the SAkuraStar study (NCT02073279). In SAkuraSky, Enspryng was examined in combination with an immunosuppressive basic treatment and in SAkuraStar as monotherapy.

Enspryng was developed to prevent NMOSD flare-ups by inhibiting the activation of the IL-6 signaling pathways, which is a key influencing factor in NMOSD. Enspryng is currently approved in 54 countries including Japan, the US and EU countries.

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