{"id":1319,"date":"2020-06-17T03:36:40","date_gmt":"2020-06-17T03:36:40","guid":{"rendered":"https:\/\/bengalnewstimes.com\/fda-oks-second-treatment-for-neuromyelitis-optica-spectrum-disorder\/"},"modified":"2020-06-17T03:36:40","modified_gmt":"2020-06-17T03:36:40","slug":"fda-oks-second-treatment-for-neuromyelitis-optica-spectrum-disorder","status":"publish","type":"post","link":"https:\/\/bengalnewstimes.com\/?p=1319","title":{"rendered":"FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder"},"content":{"rendered":"<p><\/p>\n<div>\n<p>                            <img decoding=\"async\" alt=\"News Picture: FDA OKs Second Treatment for Neuromyelitis Optica Spectrum Disorder\" class=\"healthday_image\" src=\"https:\/\/media.healthday.com\/Images\/icimages\/fda.jpg\"\/><\/p>\n<p>SUNDAY, June 14, 2020 (HealthDay News) &#8212; Uplizna (inebilizumab-cdon) injection is now approved to treat <a href=\"https:\/\/www.medicinenet.com\/devics_syndrome\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">neuromyelitis optica<\/a> spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody positive, the U.S. Food and Drug Administration announced Thursday.<\/p>\n<p>Uplizna, approved for intravenous use, is the second treatment for NMOSD approved within the past year. There are an estimated 4,000 to 8,000 patients with NMOSD in the United States, the agency noted.<\/p>\n<p>The approval was based on clinical data from 230 adult patients, 213 of whom were anti-AQP4 antibody positive. During the study, which lasted for 197 days, the 161 anti-AQP4 antibody positive patients treated with Uplizna had a 77 percent reduction in NMOSD relapse compared with patients who received placebo. The researchers found no evidence of a benefit in patients who were anti-AQP4 antibody negative.<\/p>\n<p>The most commonly reported adverse reactions included <a href=\"https:\/\/www.medicinenet.com\/urinary_tract_infection\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">urinary tract infection<\/a>, <a href=\"https:\/\/www.medicinenet.com\/headache\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">headache<\/a>, <a href=\"https:\/\/www.medicinenet.com\/arthritis\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">arthralgia<\/a>, <a href=\"https:\/\/www.medicinenet.com\/nausea_and_vomiting\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">nausea<\/a>, and <a href=\"https:\/\/www.medicinenet.com\/low_back_pain\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">back pain<\/a>. The prescribing information for Uplizna includes warnings for infusion reactions, potential hypogammaglobulinemia, and a potential increased risk for infection, including <a href=\"https:\/\/www.medicinenet.com\/dementia_pictures_slideshow\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"slide\">progressive multifocal leukoencephalopathy<\/a>, reactivation of <a href=\"https:\/\/www.medicinenet.com\/hepatitis_b\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">hepatitis B<\/a>, and <a href=\"https:\/\/www.medicinenet.com\/tuberculosis_tb_facts\/article.htm\" onclick=\"wmdTrack('embd-lnk');\" rel=\"dt\">tuberculosis<\/a>.<\/p>\n<p>Approval was granted to Viela Bio.<\/p>\n<p><a href=\"https:\/\/www.fda.gov\/news-events\/press-announcements\/fda-approves-new-therapy-rare-disease-affecting-optic-nerve-spinal-cord\" target=\"_new\" rel=\"noopener noreferrer\">More Information<\/a><\/p>\n<p class=\"credits\"><img decoding=\"async\" alt=\"MedicalNews\" border=\"0\" src=\"https:\/\/images.medicinenet.com\/images\/HealthDay\/healthday.png\" style=\"border: none;\"\/><br \/>Copyright \u00a9 2020 HealthDay. All rights reserved.<\/p>\n<p>                            <!--CONTINUEREADING--><br \/>\n<a class=\"mediaPrmo ss\" href=\"https:\/\/www.medicinenet.com\/brain_foods_pictures_slideshow\/article.htm\" onclick=\"wmdTrack('ssprmo-arttop');\" target=\"_blank\" rel=\"noopener noreferrer\">&#13;<br \/>\n    <img decoding=\"async\" src=\"https:\/\/images.medicinenet.com\/\/images\/slideshow\/brain_foods_s1_assorted_smoothies.jpg\"\/><span class=\"skew\"\/>&#13;<br \/>\n    <span class=\"icon-slideshow\"\/>&#13;<\/p>\n<h4 class=\"label\">SLIDESHOW<\/h4>\n<p>&#13;<br \/>\n    <span class=\"caption\">Brain Food Pictures: What to Eat to Boost Focus<\/span>&#13;<br \/>\n    <span class=\"btn\">See Slideshow<\/span>&#13;<br \/>\n<\/a><\/p><\/div>\n<p><script>\n!function(f,b,e,v,n,t,s){if(f.fbq)return;n=f.fbq=function(){n.callMethod?\nn.callMethod.apply(n,arguments):n.queue.push(arguments)};if(!f._fbq)f._fbq=n;\nn.push=n;n.loaded=!0;n.version='2.0';n.queue=[];t=b.createElement(e);t.async=!0;\nt.src=v;s=b.getElementsByTagName(e)[0];s.parentNode.insertBefore(t,s)}(window,\ndocument,'script','\/\/connect.facebook.net\/en_US\/fbevents.js');<\/p>\n<p>fbq('init', '428750600651790');\nfbq('track', \"PageView\");<\/script><br \/>\n<br \/><a href=\\\"http:\/\/www.medicinenet.com\/script\/main\/art.asp?articlekey=234760\\\">Source link <\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>SUNDAY, June 14, 2020 (HealthDay News) &#8212; Uplizna (inebilizumab-cdon) injection is now approved to treat neuromyelitis optica spectrum disorder (NMOSD) in patients who are anti-aquaporin-4 (AQP4) antibody positive, the U.S. Food and Drug Administration announced Thursday. Uplizna, approved for intravenous use, is the second treatment for NMOSD approved within the [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":634,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"spay_email":"","footnotes":""},"categories":[11],"tags":[],"class_list":["post-1319","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-life-style"],"jetpack_featured_media_url":"https:\/\/bengalnewstimes.com\/wp-content\/uploads\/2020\/06\/1592022296_fb-mnet-default.jpg","_links":{"self":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/posts\/1319","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=1319"}],"version-history":[{"count":0,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/posts\/1319\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=\/wp\/v2\/media\/634"}],"wp:attachment":[{"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=1319"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=1319"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bengalnewstimes.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=1319"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}