'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 to be treated at home,' said Chugai's President and CEO, Dr.
The efficacy and safety of Enspryng has been evaluated in large clinical trials representative of the real-world population of people with NMOSD, including those who have only experienced a single NMOSD attack and adolescents. The approval by the
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 54 countries including
The impact on the consolidated financials for the fiscal year ending
Self-administration is not covered in
Subcutaneous administration at 2-week intervals up to the fourth week of treatment and at 4-week intervals thereafter
Reference
New Data of Chugai's Enspryng (Satralizumab) on Risk and Severity of Relapse in Neuromyelitis Optica Spectrum Disorder (NMOSD) (
SAkuraSky study
Results from Phase III SAkuraSky Study for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder Published in
SAkuraStar study
Positive Results from the Second Phase III SAkuraStar Study for Chugai's Satralizumab in Neuromyelitis Optica Spectrum Disorder (NMOSD) Published in The Lancet Neurology (
About neuromyelitis optica spectrum disorder (NMOSD)1
NMOSD is an autoimmune disease of the central nervous system characterized by inflammatory lesions in the optic nerves and spinal cord, and causes a continual and significant decrease in quality of life due to permanent neurological disability. Patients with NMOSD frequently experience a relapsing disease course with repeated attacks leading to accumulating neurological damage and disability. Symptoms may include visual impairment, motor disability, pain leading to decreased quality of life. In some cases, attacks of NMOSD result in death.
Trademarks used or mentioned in this release are protected by law.
Sources
1. Neuromyelitis optica spectrum disorder (NMOSD) Online. https://nmosd-online.jp/ Accessed
2. Jarius S, Ruprecht K, Wildemann B et al. Contrasting disease patterns in seropositive and seronegative neuromyelitis optica: A multicentre study of 175 patients. J Neuroinflammation 2012;9:14.
3. Lennon
4. Marignier R, Bernard-Valnet R, Giraudon P et al.
5. Takahashi T, Fujihara K, Nakashima I et al. Anti-aquaporin-4 antibody is involved in the pathogenesis of NMO: a study on antibody titre. Brain 2007;130:1235-43.
6. Chihara N, Aranami T, Sato W et al. Interleukin 6 signaling promotes anti-aquaporin 4 autoantibody production from plasmablasts in neuromyelitis optica.
7. Kimura A, Kishimoto T. IL-6: regulator of Treg/Th17 balance. Eur J Immunol 2010;40:1830-5.
8. Lin J, Li X, Xia J. Th17 cells in neuromyelitis optica spectrum disorder: a review. Int J Neurosci2016;126:1051-60.
9. Takeshita Y, Obermeier B, Cotleur AC, et al. Effects of neuromyelitis optica-IgG at the blood-brain barrier in vitro. Neurol Neuroimmunol Neuroinflamm. 2016;4(1):e311.
10. Obermeier B, Daneman R, Ransohoff RM. Development, maintenance and disruption of the blood-brain barrier. Nat Med 2013;19:1584-96.
Contact:
Media
Tel: +81-3-3273-0881
E-mail: pr@chugai-pharm.co.jp
US
Media
Casey Astringer
Tel: +1-908-516-1350
E-mail: pr@chugai-pharm.com
European
Media
Tel: +44-20-8987-5680
E-mail: pr@chugai.eu
Taiwanese
Media
Tel: +886-2-2715-2000
E-mail: pr@chugai.com.tw
Investors
Tel: +81-3-3273-0554
E-mail: ir@chugai-pharm.co.jp
(C) 2021 Electronic News Publishing, source