Innovative drug for optic neurospinal corditis spectrum disorder (NMOSD)! Roche IL-6R monoantigen-resistant Enspryng significantly reduces the severity and risk of recurrence!

!-- 11, 2020 /PRY/ -- Roche recently released the latest data on the treatment of the anti-inflammatory drug Enspryng (NMOSD) at the 8th ACTRIMS-ECTRIMS Joint Conference MSVirtual2020.
results showed that Enspryng significantly reduced the severity and risk of recurrence of NMOSD and the recurrence severity of the Sakura Star Phase 3 study (SakuraStar, SAkuraSky).
addition, aggregated data from the SAkura Open Label Extension (OLE) study supports the ongoing effects of long-term use of Enspryng to reduce the risk of recurrence.
data continues to show that Enspryng has favorable security characteristics.
NMOSD is a rare, lifelong, debilitating autoimmune disease of the central nervous system, often misdiagnosed as multiple sclerosis (MM).
NMOSD mainly damages the optic nerve and spinal cord, leading to blindness, muscle weakness and paralysis.
Enspryng is a humanized monoclonal antibody that targets the binding of interlethytin 6 subjects (IL-6R), and IL-6R is believed to play a key role in inflammation in NMOSD patients.
, Enspryng received FDA approval to treat adult patients with anti-water channel protein-4 (AQP4) antibody-positive NMOSD.
It's worth noting that Enspryng is the first and only fdate-approved subsethic treatment for AQP4 antibody-positive NMOSD, which can be injected every 4 weeks by the patient himself or his caregiver.
same time, Enspryng is the first and only treatment that targets the treatment of NMOSD that inhibits the activity of lecytocytocin-6000 (IL-6R).
In two key Phase III studies (SakuraStar, SAkuraSky), Enspryng, as a monotherapy and as an additional therapy for baseline immunosuppressant therapy (IST), showed strong efficacy in a wide range of NMOSD patient populations and significantly reduced the risk of recurrence.
The Enspryng data published on MSVirtual20 is promising and shows that it significantly reduces the severity and frequency of relapses, which is an important goal for the treatment of patients with NMOSD," said Anthony Traboulsee, chair of research at the MS Society of Canada and a professor at the University of British Columbia.
Ispryng is the first NMOSD treatment approved for use at home and has good efficacy and safety, which is important for improving long-term prognosis.
" MSVirtual 2020 showed that in an after-the-fact analysis of Enspryng's treatment group, Enspryng reduced the risk of severe recurrence by 79 percent (5 out of 27 cases.
prevention of recurrence is the primary goal of NMOSD disease management, the most serious of which can lead to cumulative, irreversible nerve damage and disability.
the Enspryng treatment group was less likely to need resuscitation resuscitation than the placebo group (OR=0.46; 95% CI: 0.25-0.86, p=0.015).
if the recurrence results in a change of 2 points on the extended disability scale, it is classified as a severe recurrence.
in a separate summary analysis, Enspryng reduced the risk of recurrence by 51% (HR-0.49; 95% CI:0.31-0.79; p-0.002) compared to patients originally in the placebo group.
this effect was more pronounced in sero-positive patients with water channel protein-4 antibodies (AQP4-IgG), who had a more severe course of disease and a 66% lower risk of recurrence (HR-0.34; 95% CI:0.19-0.62; p-lt;0.001) compared to the placebo group.
In the double-blind period, the Ensprying treatment group in the SAkuraStar study had a lower infection rate than the placebo group (99.8 vs 162.6 events/100 patient years (PY)), while there was no difference in infection rates between the groups in the SAkuraSky study.
in each study, the rates of severe infection were comparable between two groups (SAkuraSky study: 2.6 vs. 5.0 events/100PY; SAkuraStar study: 5.2 vs 9.9 events/100PY).
In the combined double-blind and OLE phases, the infection and severe infection rates of patients treated with Enspryng were consistent with the nature and occurrence of adverse events in patients with double-blindness and did not increase over time.
Spryng's long-term data reinforce the efficacy of previously observed debilitating diseases that are often mistaken for multiple sclerosis (MS)," said Dr. Levi Garraway, chief medical officer and head of global product development at Roche.
Enspryng is the first and only FDA-approved subdern self-administration therapy for NMOSD and the first NMOSD drug to target lecytokine-6000 (IL-6R), which is thought to play a key role in inflammation associated with the disease.
"NMOSD" (Photo: empr.com) NMOSD is usually associated with pathogenic antibodies (anti-AQP4 antibodies), which target and damage a specific cell called astrological glial cells, leading to inflammatory lesions in the optic nerve, spinal cord, and brain.
anti-AQP4 antibodies can be detected in the serum of about 70-80% of NMOSD patients, who tend to experience more severe illnesses.
most cases of NMOSD can be diagnosed through diagnostic testing, up to 30% of patients are often misdiagnosed as multiple sclerosis (MM).
!--/ewebeditor:page--!--ewebeditor:page-title"--Enspryng is a human-based monoclonal antibody that targets the binding of lebinin 6 subjects (IL-6R), and IL-6R is believed to play a key role in inflammation in NMOSD patients.
the drug was developed by Roche's Chugai Pharma using a new antibody recovery technology.
compared to conventional techniques, this technique extends the duration of antibody circulation, maximizes the suppression of IL-6 signals, and minimizes the safety risk in chronic diseases.
patients with NMOSD experience unpredictable and severe relapses, leading directly to cumulative, irreversible nerve damage and disability.
prevention of recurrence through early treatment can have a positive impact on disability prevention, which is the primary goal of NMOSD disease management.
so far, Enspryng has been approved to treat NMOSD in Canada, Japan, Switzerland and the United States and is under review by regulators in the European Union and China.
in Japan, the United States, the European Union, satralizumab have been awarded the Orphan Drug Qualification (ODD), and in the United States was also awarded the Breakthrough Drug Qualification (BTD).
NMOSD field: There are also two drugs on the market - C5 supplement inhibitor Soliris, B cell expendable upliznaNMOSD new drug, in late June 2019, Alexion's first supplement inhibitor Soliris (eculizumab) was approved by the U.S. FDA for anti-AQP4 antibody-positive NMOSD adult patients.
the end of August 2019, Soliris was approved by the European Union for use in adult patients with AQP4 antibody-positive NMOSD with a relapse process.
the United States and the European Union, Soliris was the first drug to be approved for NMOSD.
June, Viela Bio's anti-CD19 monoantigen drug Uplizna (formerly KNOWN-551) was approved by the U.S. FDA as a two-time-a-year maintenance program after the initial dose to treat adult patients with anti-AQP4 antibody-positive NMOSD.
it is worth noting that Uplizna is the first and only B-cell expendable approved for the treatment of adult patients with AQP4 antibody-positive NMOSD.
Uplizna's active pharmaceutical ingredient, inebilizumab, is an humanized CD19-oriented monoclonal antibody with a high affinity with CD19, a protein widely expressed in B cells, including pulp cells that secrete antibodies and some plasma cells.
combined with CD19, these cells quickly drain from the circulatory system.
the end of May 2019, Hansoh Pharma entered into a strategic partnership with Viela Bio to develop in-inebilizumab in China for the treatment of NMOSD and other potential inflammatory/autoimmune and hematological malignancies.
terms of the agreement, Viela Bio is eligible for an upfront partnership fee and a milestone payment of more than $220 million, as well as tiered royalties based on net product sales.
Pharmaceuticals will lead the development and commercialization of in-inebilizumab in China.
the original source: New data show Roche's ENSPRYNG (satralizumab) greatly reduces severity and risk of relapse in neuromyelitis optica spectrum !--/ewebeditor:page.