Janssen Announces U.S. FDA Approval of PONVORY ™ (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio® (teriflunomide) in Reducing Annual Relapses and Brain Lesions

TITUSVILLE, N.J. – (March 19, 2021) – The Janssen Pharmaceutical Companies of Johnson &Johnson today announced that the U.S. Food and Drug Administration (FDA) approved PONVORY™ (ponesimod), a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease.1,2,3 PONVORY™ offers MS patients superior efficacy in reducing annualized relapse rates compared to an established oral therapy and a proven safety profile backed by over a decade of cumulative clinical research.3,4,5 The FDA approval is based, in part, on a two-year, head-to-head Phase 3 clinical trial in which PONVORY™ 20 mg demonstrated superior efficacy in significantly reducing annual relapses by 30.5% compared to teriflunomide (Aubagio®) 14 mg in patients with relapsing MS.3 Over the study period, 71% of patients treated with PONVORY™ had no confirmed relapses, compared to 61% in the teriflunomide group.3 PONVORY™ was also superior to teriflunomide in reducing the number of new gadolinium-enhancing (GdE) T1 lesions and the number of new or enlarging T2 lesions by 59% and 56%, respectively.3 GdE T1 lesions and T2 lesions are identified using magnetic resonance imaging (MRI) technology and are recognized as classic measures of MS pathology that can provide insights into disease activ...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news

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Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part BAuthor(s): Yanhua Liu, Yang Li, Shanshan Dong, Lu Han, Ruixin Guo, Yourong Fu, Shenghu Zhang, Jianqiu Chen
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
Publication date: 15 February 2021Source: Journal of Hazardous Materials, Volume 404, Part BAuthor(s): Jinsoo Lee, Seong-Jin Choi, Ji-Seong Jeong, Sang Yun Kim, Sang-Hyub Lee, Mi Jin Yang, Seung-Jin Lee, Young-Jun Shin, Kyuhong Lee, Eun Ju Jeong, Sang-Yoon Nam, Wook-Joon Yu
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
Publication date: Available online 30 September 2020Source: Journal of Hazardous MaterialsAuthor(s): Anthony Beauvois, Delphine Vantelon, Jacques Jestin, Martine Bouhnik-Le Coz, Charlotte Catrouillet, Valérie Briois, Thomas Bizien, Mélanie Davranche
Source: Journal of Hazardous Materials - Category: Environmental Health Source Type: research
Source: Journal of Toxicology and Environmental Health Part A - Category: Environmental Health Authors: Source Type: research
We describe the most highly recommended generic and disease-specific PRO tools in SCD and discuss the challenges of incorporating them in clinical practice. EXPERT OPINION: PRO measures are essential to incorporate into SCD clinical trials either as primary or secondary outcomes. The use of PRO measures in SCD facilitates a patient-centered approach, which is likely to lead to improved outcomes. Significant challenges remain in adapting PRO tools to routine clinical use and in developing countries. PMID: 33034214 [PubMed - as supplied by publisher]
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
Authors: Musio F Abstract INTRODUCTION: Anemia has and will continue to be a central theme in medicine particularly as clinicians are treating a burgeoning population of complex multi-organ system processes. As a result of multiple randomized controlled trials (RCTs), meta-analyses, and societal recommendations overly restrictive paradigms and under-administration of erythropoiesis stimulating agents (ESAs) have likely been followed by clinicians among all specialties. AREAS COVERED: A review of anemia in the context of chronic kidney disease, hematologic malignancies and cancer is presented with focus on the e...
Source: Expert Review of Hematology - Category: Hematology Tags: Expert Rev Hematol Source Type: research
Authors: Bergland OU, Søraas CL, Larstorp ACK, Halvorsen LV, Hjørnholm U, Hoffman P, Høieggen A, Fadl Elmula FEM Abstract PURPOSE: The blood pressure (BP) lowering effect of renal sympathetic denervation (RDN) in treatment-resistant hypertension shows variation amongst the existing randomised studies. The long-term efficacy and safety of RDN require further investigation. For the first time, we report BP changes and safety up to 7 years after RDN, compared to drug adjustment in the randomised Oslo RDN study. MATERIALS AND METHODS: Patients with treatment-resistant hypertension, defined...
Source: Blood Pressure - Category: Hematology Tags: Blood Press Source Type: research
Authors: Zhang W, Xu JZ, Lu XH, Li H, Wang D, Wang JG Abstract PURPOSE: We hypothesise that dietary sodium intake interacts with serum uric acid to influence blood pressure (BP) in children and adolescents. In the present study, we investigated ambulatory BP in relation to hyperuricaemia, dietary sodium intake and their interaction in children and adolescents with hypertension. MATERIALS AND METHODS:  A total of 616 study participants were 10-24 years old and had primary hypertension diagnosed after admission in a specialised inpatient ward. Ambulatory BP monitoring was performed during hospitalisat...
Source: Blood Pressure - Category: Hematology Tags: Blood Press Source Type: research
Publication date: January 2021Source: Safety Science, Volume 133Author(s): Helen Lingard, Tracy Cooke, Greg Zelic, James Harley
Source: Safety Science - Category: Occupational Health Source Type: research
Authors: Sabet Sarvestani F, Azarpira N Abstract Heart and cerebral infarctions, as two important ischemic diseases, lead to the death of tissues due to inadequate blood supply and high mortality worldwide. These statuses are started via blockage of vessels and depletion of oxygen and nutrients which affected these areas. After reperfusion and restoration of oxygen supply, more severe injury was mediated by multifaceted cascades of inflammation and oxidative stress. microRNAs (miRNAs) as the regulator of biological and pathological pathways can adjust these conditions by interaction with their targets. Also, miRNAs...
Source: Immunological Investigations - Category: Allergy & Immunology Tags: Immunol Invest Source Type: research
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