New drug for optic neurospinal itis spectrum disorder (NMOSD) Roche IL-6R single anti-Enspryng (satralizumab) approved in Japan!

, June 29, 2020 //Biovalley
BIOON/-- Roche has announced that Japan's Ministry of Health, Labour (MHLW) has approved Enspryng (satralizumab) for the treatment of the optic nerve cord Inflammatory spectrum disorder (NMOSD, including NMO), the drug specific indications are: for water channel protein-4 antibodies (AQP4-IgG) seropositive children and adults, to prevent the recurrence of NMOSD (including NMO)In two key Phase III studies, Enspryng, as a monotherapy and as an additional therapy for baseline immunosuppressant therapy (IST), showed strong efficacy in a wide range of NMOSD patient groups and significantly reduced the risk of recurrenceIn terms of medication, Enspryng is injected under the skin every 4 weeksin Japan, Enspryng was approved through a priority reviewRecently, the drug has also been approved in Canada through priority review, and indications are consistent with the aboveIn October 2019, the U.SFDAand the European Union's EMA accepted applications for the listing of Enspryng for nMOSD, and is expected to make a decision on approval in 2020In China, in April 2020, the National Drug Administration (NMPA) Drug Review Center (CDE) received Applications for listing of EnspryngOrphan Medicine (ODD) has been granted in Japan, the United States, the European Union and satralizumab, and the Breakthrough Drug (BTD) in the United StatesNMOSD is a rare, lifelong, degenerativeautoimmunedisease, usually associated with pathogenic antibodies (AQP4-IgG), which target and damage a specific cell called astrocytecells, leading to inflammatory lesions in the optic nerve, spinal cord, and brainAQP4-IgG antibodies can be detected in the serum of approximately 70-80% of NMOSD patients, who tend to experience more severe diseaseAlthough most cases of NMOSD can be diagnosed through diagnosis tests, up to 30% of patients are still being misdiagnosed as multiple sclerosis (MM) Enspryng is a humanized monoclonal antibody against the interleukin 6 receptor (IL-6R), which is thought to play a key role in inflammation in patients with NMOSD The drug was developed by Roche's Chugai Pharma using a new antibody recycling technology Compared to traditional techniques, this technique extends the duration of the antibody cycle, suppresses IL-6 signals to the maximum extent, and minimizes the safety risks of chronic diseases Patients with NMOSD experience unpredictability of severe, unpredictable relapses that directly lead 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 "Today's approval in Japan is the first approval by Enspryng in Asia and offers a new treatment option that helps reduce NMOSD recurrence," said Dr Levi Garraway, Chief Medical Officer and Global Product Development Officer at Roche Recurrence of NMOSD can lead to irreversible disabilities, such as vision loss and paralysis In Japan, the prevalence of NMOSD is high among adults and children, but the approved treatment options are limited Enspryng is the first and only approved treatment for interleukal interleukin-6 (IL-6) receptors, which are approved and is the only one "
NMOSD (Photo Source: empr.com) Enspryng was approved in Japan, based on data from two global Phase III clinical studies (SakuraStar, SAkura Sky), which evaluated the efficacy and safety of satralizumab as a single drug therapy and with baseline immunosuppressants (IST) - SAkuraStar study: is a multicenter, randomized, double-blind, placebo-controlled study that enrolled 90 men and women aged 18-74 with NMOSD patients, evaluating the efficacy and safety of satralizumab The patients enrolled in the study were NMO patients with AQP4 antibodies (according to the 2006 diagnostic criteria) and NMOSD patients (according to the 2007 diagnostic standard) In the study, these patients were randomly assigned to two groups at a ratio of 2:1: the satralyzumab (120 mg) treatment group, the placebo group Satralizumab and placebo were administered at subcutaneous injections at 0, 2 and 4 weeks, and follow-up treatment was given once every 4 weeks The double-blind period ends when the total number of recurrences defined by clinical protocol (44 cases) or the last patient is entered 1.5 years after entering the group (regardless of which occurs first) After that, patients in 2 treatment groups entered the open label extension period and could continue to receive satralizumab treatment The main endpoint of the study was the recurrence time defined by the first agreement determined by the Independent Review Board during the double-blind period The main secondary endpoints include the Visual Simulation Scale (VAS) pain score, and the Chronic Disease Functional Evaluation Scale (FACIT) fatigue score data show that :1 The study reached the primary endpoint, and that the single drug treatment of satralizumab reduced the risk of recurrence by 55% compared to placebo in the overall study population (HR.45, 95% CI: 0.23-0.89, p-0.0184) In the larger subgroup (about 67%) - AQP4-Ig4 antibody serotonin-positive patients, satralizumab treatment was more effective, the risk of recurrence was significantly reduced by 74% (HR-0.26, 95% CI: 0.11-0.63, p-0.0014) AQP4-IgG serotonin-positive patients often experience a more serious disease process (2) In the whole population treated with satralizumab, 76.1% did not relapse at 48 weeks, 72.1% did not relapse at 96 weeks, compared with 61.9% and 51.2% of the placebo group, respectively Data from the AQP4-IgG seropositive subgroup showed that patients treated with satralizumab had a recurrence rate of 82.9 percent at 48 weeks, 76.5 percent at 96 weeks, and 55.4 percent and 41.1 percent, respectively, in the placebo group - SAkuraSky study: is a multicenter, randomized, double-blind, placebo-controlled study in a group of 83 patients with NMOSD who evaluated the efficacy and safety of satralizumab added to baseline therapy In the study, patients were randomly assigned to 2 treatment groups at a ratio of 1:1: satralyzumab (120 mg) or placebo added to baseline therapy (thiopentalin, mycophenolite and/or glucocorticoids) Satralizumab and placebo were administered at subcutaneous injections at 0, 2 and 4 weeks, and follow-up treatment was given once every 4 weeks The double blind period ends when the total number of relapses defined by the agreement is reached After that, patients in 2 treatment groups entered the open label extension period and could continue to receive satralizumab treatment data show that: (1) satralizumab-baseline immunosuppressive therapy significantly reduced the risk of relapse in NMOSD patients (including AQP4 antibody-positive and negative patients) by 62% (HR.38 (95% CI: 0.16-0.88), p-0.0184), and reached the primary endpoint of the recurrence of the first protocol in the double-blind period (PDR) In weeks 48 and 96, the proportion of non-recurrence patients in the satralizumab treatment group was 88.9% and 77.6%, respectively, and 66% and 58.7% in the placebo group, respectively (2) Pre-specified subgroup analysis results show edited that satralizumab significantly reduced The risk of PDR by 79% compared to placebo in AQP4 antibody-positive subgroup patients (n-55) (HR-0.21 .95% CI: 0.06-0.75)), week 48 and 96, the proportion of non-recurrence patients in the satralizumab treatment group was 91.5% and 91.5%, respectively, and the placebo group was 59.9% and 53.3%, respectively In patients in the AQP4 antibody-negative subgroup (n-28), satralizumab reduced The risk of PDR by 34% compared to placebo (HR.66 (95% CI: 0.20-2.23), and in weeks 48 and 96, the proportion of non-relapsed patients in the satrazumab treatment group was 84.4% and 56.3%, respectively, and the placebo group was 7.57% overall, in both studies, the proportion of patients with severe adverse events in the satralyzumab treatment group and the placebo group was similar The infection rate (including severe infections) in the satralizumab treatment group was lower than in the placebo group Most adverse reactions were light to moderate, and the most common adverse reactions in the Satralizumab treatment group : urinary tract infections and upper respiratory tract infections in the SAkuraStar study, upper respiratory tract infections, nasopharyngeitis (common cold) and headaches in the SAkuraSky study the data from the above two controlled, randomized Phase III clinical trials , satralizumab is an effective treatment option, whether used as a single drug or in combination with baseline therapy Satralizumab is injected every four weeks, which can be a convenient option for patients and caregivers NMOSD field: 2 drugs approved - C5 supplement inhibitor Soliris, B-cell consumer Uplizna NMOSD is a rare, lifelong, negotiable autoimmune disease characterized by inflammatory diseases of the optic nerve and spinal cord Patients with NMOSD often experience recurrent disease, with recurrent episodes leading to progressive accumulation of nerve damage and disabilities, with symptoms including visual impairment, motor impairment and decreased quality of life In some cases, NMOSD attacks can result in death NMOSD is usually associated with pathogenic antibodies (water channel protein-4 (AQP4) -IgG), which targets and damages a specific cell type called astrocytes, leading to inflammatory damage to the optic nerve, spinal cord, and brain Most Patients with NMOSD were identified as AQP4-IgG serotonin positive through diagnostic biomarker testing; This condition is often misdiagnosed as multiple sclerosis satralizumab is a human-derived monoantine that targets IL-6 receptors to inhibit IL-6 signal conduction IL-6 is a cytokine that is thought to play a key role in nMOSD inflammation, triggering an inflammatory cascade reaction, leading to injury and disability Patients with NMOSD experience an unpredictable and severe relapse that leads directly to cumulative, permanent nerve damage note, at the end of June 2019, Soliris, the pioneering supplement inhibitor of rare disease giant Alexion, received a U.S FDA approved for anti-water channel protein-4 (AQP4) antibody-positive optic neurospinal itis spectrum disorder (NMOSD) in adult patients At the end of August 2019, Soliris was again approved by the European Union for Use in AQP4 antibody-positive adult patients with a complex course of onset Soliris is the first drug approved for NMOSD in the United States and the European Union June this year, Viela Bio's anti-CD19 monoantitic drug Uplizna (inebilizumab-cdon), formerly known as MEDI-551, was approved by the U.S FDA , after the initial dose as a two-time maintenance program for the treatment of anti-water channel protein-4 (AQP4) antibody-positive NMOSD adult patients It is worth mentioning that Uplizna is the first and only B-cell consuming agent approved for the treatment of AQP4 antibody-positive NMOSD adult patients Uplizna's active pharmaceutical ingredient inebilizumab is a human-derived CD19-oriented monoclonal antibody with a high affinity with CD19, a protein widely expressed in B cells, including plasma cells that secrete antibodies and some pulp cells When inebilizumab binds to CD19, these cells quickly drain from the circulatory system the end of May 2019, Hansoh Pharma has entered into a strategic partnership with Viela Bio to develop inebilizumab in China to treat NMOSD and other potential inflammatory/
autoimmune and hematologic malignant tumors indications Under the 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 sales of the product Howson Pharmaceuticals will be responsible for leading the development and commercialization of inebilizumab in China (BioValleyBioon.com) original origin: Roche's ENSPRYNG ®️ (satralizumab) approved in Japan for adults and children with neuromyelitis optica spectrum .