Chugai Pharmaceutical announced that Roche has received notification that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of the pH-dependent binding humanized anti-IL-6 receptor monoclonal antibody Enspryng (satralizumab), created by Chugai, as the first subcutaneous treatment option for adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST).
“We are pleased that Enspryng is expected to be approved in the EU for the treatment of NMOSD, a disease with limited treatment options that causes visual impairment and neurological disability,” Chugai’s President and CEO Dr. Osamu Okuda said in a company news release. “Enspryng is effective in the prevention of NMOSD relapses and well tolerated in people with AQP4-IgG seropositive NMOSD as shown in two global phase 3 studies. Enspryng is expected to be the first approved product in the EU to apply our proprietary recycling antibody technology, and the first NMOSD treatment targeting the IL-6 receptor to enable people with NMOSD to be treated at home by self-injection* through subcutaneous administration.”
Enspryng has been evaluated for efficacy and safety in clinical trials in NMOSD including people who have only experienced a single NMOSD attack and adolescents, and is expected to be approved in the EU. The positive recommendation is based on the results from two global phase 3 clinical studies in people with NMOSD: SAkuraSky Study (NCT02028884) and SAkuraStar Study (NCT02073279). SAkuraSky evaluated Enspryng in combination with baseline immunosuppressive treatment, and SAkuraStar assessed monotherapy.
Enspryng is designed to prevent NMOSD relapses by inhibiting IL-6 signal signaling which is a key driver in NMOSD. Enspryng is currently approved in 20 countries including Japan and the United States.
The impact on the consolidated financials for the fiscal year ending December 2021 of Chugai is expected to be negligible.
*Self-administration is not included in Japanese package insert
**Subcutaneous administration at 2-week intervals up to the fourth week of treatment and at 4-week intervals thereafter
New Data of Chugai’s Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) (September 10, 2020)
• SAkuraSky study
Results from Phase III SAkuraSky Study for Chugai’s Enspryng in Neuromyelitis Optica Spectrum Disorder Published in The New England Journal of Medicine Online (November 29, 2019)
• SAkuraStar study
Positive Results from the Second Phase III SAkuraStar Study for Chugai’s Enspryng in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (April 24, 2020)