Neurospinal itis spectrum disorder (NMOSD) the first B-cell consumer! FDA approved CD19 single anti-Uplizna, Haussen Pharmaceuticals introduced to China!

JUNE 12, 2020 /PRNEWSWIRE/ -- VIELA BIO IS HEADQUARTERED IN GAITHERSBURG, MD., A BIOPHARMACEUTICAL COMPANY THAT IS SPUN OFF FROM MED IMMUNE, A GLOBAL BIOLOGICS RESEARCH AND DEVELOPMENT ARM OF ASTRAZENA, FOCUSING ON THE DEVELOPMENT OF INNOVATIVE DRUGS IN THE FIELD OF INFLAMMATION AND AUTOIMMUNE DISEASESRecently, the company announced that the U.SFood and Drug Administration (FDA) has approved its anti-CD19 monoantine uplizna (inezumab-cdon), formerly known as MEDI-551, as a two-time maintenance program after the initial dose to treat patients with the anti-water channel protein-4 (AQP4) antibody-positive visual neurospinal spectrum disorder (NMOSDD)It is estimated that about 80% of NMOSD patients test positive against AQP4 antibodiesPreviously, the FDA has granted inebilizumab the Orphan Drug (ODD) and Breakthrough Drug (BTD) for the treatment of NMOSDIt is worth mentioning that Uplizna is the first and only B-cell consuming agent approved for the treatment of AQP4 antibody-positive NMOSD adult patientsUplizna's active drug ingredient inebilizumab is a humanized CD19-oriented monoclonal antibody with a high affinity with CD19, a protein widely expressed in B cells, including plasma mother cells that secrete antibodies and some plasma cellsWhen inebilizumab binds to CD19, these cells quickly drain from the circulatory systemAt the end of May 2019, Hansoh Pharma entered into a strategic partnership with Viela Bio to develop inebilizumab in China for NMOSD and other potential inflammatory/autoimmune and hematologic malignancy indicationsUnder 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 productHowson Pharmaceuticals will be responsible for leading the development and commercialization of inebilizumab in ChinaThe approval, based on data from the critical N-MOmentum study, is the largest ever conducted in adult patients with real-world genealogy NMOSDThe study was a global, randomized, double-simulated, placebo-controlled study of 213 anti-AQP4 antibody-positive patients and 17 anti-AQP4 antibody-negative patientsIn the study, the patients were randomly divided into 2 groups at a 3:1 ratio, received 2 doses of 300 mg inezumab single drug or placebo on the first and 15th days, and followed up for 6.5 months (197 days)After a randomized controlled period (RCP), patients can choose to enter an open label extension period, and all patients receive 300 mg inebilizumab single drug treatment every 6 monthsThe main endpoint is the time from the beginning of treatment to the onset of NMOSDThe study ended early on the basis of efficacy evidence, according to the Independent Data Monitoring Board (IDMC) The data show ediphon: After 28 weeks of treatment, in AQP4-IgG serotonin-positive patients, inebilizumab significantly reduced the risk of a single nMOSD attack by 77% compared to placebo (HR.227, p 0.0001) In the overall treatment group (including AQP4-IgG serotonin-negative patients), inebilizumab reduced the risk of a single NMOSD attack by 73% compared to placebo (HR.272, p 0.0001) At the end of the randomized control period, 89% of AQP4-IgG seropositive patients treated with inebilizumab had no seizures, compared with 58% of the placebo group The study also reached a critical secondary endpoint: inebilizumab significantly reduced disability deterioration (15.5% vs 33.9%, p.0049), NMOSD-related hospitalization (10/174 patientvs 8/56), p-0.01, and new central nervous system MRI impairment frequency (79/174 patients 32/56, p.0333) In the study, inebilizumab had good safety and acceptable tolerance, and the rate of adverse events was similar to that of placebo Severe and/or level 3 severe adverse events were similar, with 10.3 per cent in the inbilizumab treatment group and 14.3 per cent in the placebo group The inebilizumab (MEDI-551) mechanism NMOSD is a rare, destructive, complementary-mediated autoimmune disease of the central nervous system characterized by relapses, each of which leads to a gradual accumulation of disabilities, including blindness and paralysis, and sometimes premature death In NMOSD patients, about 80% of patients have autoantibodies of water channel protein-4 (AQP4), which are thought to be produced by plasma cells and plasma cells, mainly in combination with astrocytes in the central nervous system The combination of AQP4-IgG antibodies with the central nervous system is thought to trigger attacks that damage the optic nerve, spinal cord and brain Blindness, paralysis, loss of sensation, bladder and intestinal dysfunction, nerve pain and respiratory failure can all be manifestations of the disease Each NMOSD attack can lead to further injury and disability NMOSD is more common in women and may be more common among non-white people It's worth noting that at the end of June 2019, Soliris (eculizumab), the pioneering supplement inhibitor of rare disease giant Alexion, was approved by the U.S FDA for use in adult patients with anti-water channel protein-4 (AQP4) antibody-positive osteospinal itis spectrum disorder (NMOSD) In August 2019, Soliris was again approved by the European Union for Use in Adult NMOSD patients with AQP4 antibody positive and with a recurrent course Soliris is the first drug approved for NMOSD in the United States and the European Union Currently, Roche's IL-6R mono-antisatrazumab treatment NMOSD has entered regulatory review in the United States, the European Union and Japan This is a human-derived monotoresist 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 (BioValleyBioon.com) Original source: Viela Bio Announces U.S FDA approve dat ing upLLINNA ™ (inebilizumab-cdon) for the Treatment of Neuromyelitis Optica Spectrum (NMOSD)