4th Indications! Novartis Cosentyx approved in the U.S.: Treatment of radiology-negative mid-axis spinal arthritis (nr-axSpA)

, June 17, 2020 /PRNewswireBiovalleyBIOON/ --Novartishas approved the anti-inflammatory drug Cosentyx (Chinese product name: Good, generic name: secukumab, sukiuu-singumantis, "Sukin monoantisis), commonly known as the experimental radiation negative spinal arthritis patients(nrApril this year, Cosentyx was approved in Europe, becoming the first IL-17A inhibitor to treat nr-axSpAOn the U.Sside,LillyTaltz (ixekizumab) was approved in early June as the first IL-17A inhibitor approved for nr-axSpA in the U.Smarketpreviously, Cosentyx has been approved for three indications: psycoarthritis (PsA), Plaque Psoriasis (PsO), and Aggressive Spinaitis (AS)Nr-axSpA marks the fourth indication of Cosentyx harvest and will address the entire disease spectrum (AS and nr-axSpA) of mid-axis spinal arthritis (axSpA)It is estimated that about 2.7 million people in the United States have axSpA;clinical data show edified significantly less disease activity in patients treated by Cosentyx than placebosIn particular, Cosentyx showed clinically significant results as early as the third week, and these results lasted for up to a yearWith this approval, Cosentyx will provide an important treatment option for this disease with limited treatment optionsthis approval, based on the efficacy and safety results of Phase III Clinical Study PREVENT (NCT02696031)PREVENT is the largest study evaluating patients with a biologic treatment nr-axSpA, a randomized, double-blind, placebo study designed to investigate the efficacy and safety of Patients with Cosentyx therapeutic activity nr-axSpAThe study included 555 active nr-axSpA patients (before the onset age of 45 years of age, the visual simulation scale (VAS) upper spinal pain score of 40/100, Bath strong spinal rhinolytitis disease activity index (BASDAI) 4), these patients before the start of the study received at least 2 different nonsteroidal anti-inflammatory drugs (NSAID) to treat the maximum dose for 4 weeks, may have previously received a maximum dose of TT inhibitors (but not more than one type of t-b555 patients, 501 (90.3%) had not previously been treated with biotherapy (primary treatment of biological therapy)In the study, patients were divided into three treatment groups: Cosentyx 150mg subcutaneous injection loaded dose (induced: 150mg subcutaneous injection, treatment for 4 weeks per week; maintenance: 150mg, once per month), Cosentyx 150mg subcutaneous injection stake less than a load dose (150mg subcutaneous injection, once per month), and maintenanceThe main endpoint is the 16th and 52nd weeks of treatment, and in patients with TNF primary treatment, the proportion of patients receiving Cosentyx 150mg treatment reached ASAS40 remissionSecondary endpoints include changes in BASDAI over time and changes in CRP (ASDAS-ARP) activity score for aggressive spina bifidaresults showthat that in the 16th week of treatment, the study reached the primary endpoint of ASAS40: patients with Cosentyx 150mg treated showed a statistically significant and clinical lysis in disease activity compared to patients treated with placebo (ASAS40 mitigation rate: 42.2% vs 29.2%, p.05)Secondary endpoints also showed significant statistical improvements, including pain, activity, and health-related quality of lifeTrials have shown lasting mitigation and safety consistent with previousclinical trialsNo new safety signal scan was detectedat the end of April this year, Cosentyx (®) was approved by the State Drug Administration (NMPA) for routine treatment of adult patients with ineffective severe spina bifida (AS)This is the second indication that can be approved in China following the approval of the ® in March 2019 for the treatment of moderate to severe plaque psyritus (PsO), and the first and only interlemic inhibitor approved for the treatment of aggressive spina bifida (AS) in the countryjust recently, Cosentyx (can be well-®) self-contained ® approved in ChinaAs a good ® pre-filled injection needle upgrade version, can be good ® feel at ease® will optimize the original way of administration, "one touch" operation to reduce the difficulty of injection, improve the patient's treatment experience, while effectively avoiding the drug waste caused by operational errors, for China's light large and severe plaque psoriasis patients and patients with severe spinal attack to bring more convenient, safe and efficient treatment of new experience axial spinal arthritis (axSpA) is a long-term inflammatory disease spectrum characterized by chronic inflammatory back pain The axSpA disease spectrum includes strong direct spina bifida (AS) and radiological-negative mid-axis spinal arthritis (nr-axSpA), which can see joint damage under X-rays and joint damage under X-rays BOTH AS AND Nr-axSpA have similar symptom burdens, including nighttime pain, fatigue, morning stiffness and functional disability If left untreated, axSpA can impair activity, result ingons of working hours and have a significant impact on quality of life Cosentyx is the first human monoclonal antibody drug specifically targeted to inhibit leukerin-17A (IL-17A), selectively targeting the activity of the circulating IL-17A, reducing immune system activity and improving disease symptoms Studies have revealed that IL-17A plays an important role in driving the body's immune response to a variety of autoimmune diseases, including psoriasis arthritis (PsA), plaque-type psoriasis (PsO), aggressive spinaencephalitis (AS), and nr-axSpA Cosentyx was approved for listing in January 2015 and has now been approved for four indications (PsO, PsA, AS, nr-axSpA) Cosentyx has five years of continuous efficacy and safety data on the top three indications, with more than 340,000 patients worldwide receiving the drug (BiovalleyBioon.com) original source: Novartis Cosentyx® receiving the fda app roval for new good to treat active non-radiographic axial spondyarthritilos