Roche satelizumab was approved in China, saying NO to the recurrence of optic neuromyelitis spectrum disease!

Introduction On May 7, 2021, Roche Pharmaceuticals' rare disease drug Anshiping® (English name: Enspryng®, Chinese common name: Satralizumab injection, English common name: Satralizumab Injection) was awarded by the National Medical Products Administration Officially approved, it became China's first therapeutic drug for neuromyelitis optica spectrum disease (NMOSD), which is suitable for the treatment of aquaporin 4 (AQP4) antibody-positive adolescents and adults with neuromyelitis optica spectrum disease (NMOSD) patients aged 12 years and older.

Anshiping® can effectively reduce the risk of recurrence of NMOSD.

Over 60% of patients with NMOSD are blind within 5 years.
Neuromyelitis optica spectrum disease (NMOSD) is a rare, highly recurring, and highly disabling autoimmune disease of the central nervous system, which mainly damages the optic nerve and spinal cord.
The global prevalence rate is 1.
82.
100,000.
It mostly occurs in young adults and more women.
The incidence is higher in Asian populations.

Patients will experience unpredictable relapses, and each relapse may lead to accumulation of nerve damage and disability, resulting in severe disability consequences such as blindness and paralysis, and even death.

Data show that about 60% of patients relapse within 1 year, 90% of patients relapse within 3 years [1], and the degree of disability of patients increases with the number of relapses [2].

After 5 years of illness, about 50% of patients need a wheelchair, 62% of patients are blind[3], and more serious cases even lead to death.

Frequent recurrences have brought great troubles to patients’ lives.
More than one-third of patients are in a state of long-term unemployment due to illness.
Most patients cannot take care of themselves completely in their daily lives, which brings great difficulties to NMOSD patients and their families.
Economic and psychological burden.

The disease was included in the first batch of 121 rare diseases in the country in May 2018.

Previously, China had no approved drugs to effectively reduce the risk of recurrence of NMOSD, and patients faced the dilemma of poor drug safety and limited efficacy.

The approval of Anshiping® this time fills up the gap in NMOSD remission treatment drugs in the Chinese market.

Helping patients to tell the relapse that NO's approval of satrizizumab is based on two multi-center phase III clinical studies for NMOSD patients carried out on a global scale.

Studies have shown that in adult patients with AQP4 antibody-positive NMOSD, compared with placebo, subcutaneous injections are given every 4 weeks, whether it is satelizumab combined immunotherapy or satelizumab single agent Treatment can effectively reduce the risk of recurrence and has good safety.

● The SAkuraSky study aims to evaluate the efficacy and safety of satrizizumab combined with baseline immunotherapy in the treatment of NMOSD.
The results show that compared with placebo combined with baseline immunotherapy, those who received satrizumab combined with baseline immunotherapy The patient can reduce the risk of recurrence by 62% (HR=0.
38[95%CI: 0.
16-0.
88]; p=0.
018).

In AQP4 antibody-positive patients (n=55), satrizizumab can reduce the risk of recurrence by 79% (HR=0.
21 [95%CI: 0.
06-0.
75]), 48 weeks, 96 weeks, 144 weeks The proportion of relapse-free patients in the treatment group of terlizumab combined with baseline immunotherapy (n=27) was 92%, 92%, and 85% [1].

● The SAkuraStar study aims to evaluate the efficacy and safety of satrizizumab as a single agent in the treatment of NMOSD.
The results showed that compared with the placebo group, patients who received satrizizumab as a single agent had a 55% reduction in the risk of recurrence (HR=0.
45[95%CI: 0.
23–0.
89]; p=0.
018).

In patients with positive AQP4 antibodies (n=64), satrizizumab can reduce the risk of recurrence by 74% (HR=0.
26[95%CI: 0.
11-0.
63]) for 48 weeks, 96 weeks, and 144 weeks.
The proportion of relapse-free patients in the terlizumab treatment group (n=41) was 83%, 77%, and 77%, respectively [5].

Professor Xu Xianhao, Department of Neurology, Beijing Hospital: NMOSD mainly invades the optic nerve and spinal cord.
It has the characteristics of high recurrence and high disability.
Most patients have severe visual impairment/or limb dysfunction and diuresis. Preventing recurrence through early treatment has a positive impact on preventing disability, reducing the risk of recurrence and improving symptoms are the primary tasks of treatment of NMOSD.

Satrizizumab has been approved to fill the gap in NMOSD treatment in my country, and will help patients get rid of the severe disability consequences such as blindness and paralysis caused by the high frequency of recurrence of the disease, and make NMOSD change from drugless to preventable and controllable "slow" "Illness" provides the possibility for patients to stabilize their condition and resume work.

Professor Hu Xueqiang, Department of Neurology, The Third Affiliated Hospital of Sun Yat-sen University: Many NMOSD patients are at the golden age of life, most of them have college degree or above, but they are unemployed due to illness, which prevents them who should have become the backbone of the family’s economy.
Contribute more.

Satrizizumab significantly improves the quality of life of patients with NMOSD, and greatly saves the burden of family care caused by patients with disability due to frequent relapses of the disease.
It has relatively high cost-effective advantages and adopts a subcutaneous injection every 4 weeks.
, It is a convenient choice for patients and nursing staff.
Patients can inject at home, which greatly improves the compliance and convenience of medication.

The New Deal shortens the "jet lag" between China and foreign countries, and rare disease drugs are expected to be marketed globally.
It is reported that there are 378 effective treatment drugs for rare diseases in the world, while only 92 drugs have rare disease indications on the domestic market in China.

Thanks to the Chinese government’s continuous optimization and acceleration of the approval process for imported drugs on the market and a series of measures to promote the protection of rare disease drugs, satrizizumab was given priority review in China in June 2020, and will be reviewed in 11 months.
It was formally approved afterwards.

Ms.
Zhou Hong, General Manager of Roche Pharmaceuticals China, said: "Adhering to the concept of'Patients First', Roche has long been committed to the research and development of innovative drugs in the field of rare diseases and neurological diseases.

We are very pleased that Anshiping® was approved in China this time .
In the future, we will continue to cooperate with all parties to bring more Roche's innovative drugs in the field of neurological diseases into China as soon as possible.
At the same time, we will actively explore health digital solutions to provide more innovative and individualized integration for patients in the field of neurological diseases in China and the world.
solution. "Reference: [1] Neuroimmunology Branch of Chinese Society of Immunology.
Chinese Journal of Neuroimmunology and Neurology, 2016,23(3):155-166.
[2] Wingerchuk DM, et al.
Lancet Neurol.
2007Sep;6 (9):805-15.
[3] Kessler RA, et al.
Neurol Neuroimmunol Neuroinflamm.
2016;3:e269.
[4] Yamamura T, et al.
N Engl J Med.
2019;381(22):2114- 2124.
[5] Traboulsee A, et al.
Lancet Neurol.
2020;19(5):402-412.