FDA considers Xolair for chronic idiopathic urticaria

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<script type="text/javascript"> //JS here $j(document).ready(function () { $j(".scfSubmitButton").attr("disabled","disabled"); var showModal = false; var smcookie = $j.cookie('hregshowthanks'); if(smcookie != null){ if(smcookie.length>0){ showModal = (smcookie == 'true'); } } var ctaValue = 'landingcta1'; if ($j.cookie('hregctaval') != null) { if ($j.cookie('hregctaval').length>0) { ctaValue = $j.cookie('hregctaval'); } } if(showModal){ $j(".fancybox").fancybox({afterClose:(function(){ $j.cookie('hregshowthanks','false',{expires:30,path:'/'});_gaq.push(['_trackEvent', 'Registration Process', 'CTA Form Modal Closed', ctaValue]);})}); $j(".fancybox").eq(0).trigger('click'); $j(".hregThanksModalClick").click(function (event) { $j.cookie('hregshowthanks','false',{expires:30,path:'/'}); _gaq.push(['_trackEvent', 'Registration Process', 'CTA Form Modal Click', ctaValue]); }); } var cookieHideCTA = $j.cookie('hreghidecta') == 'true'; var showCta = true; if(showCta){ // check cookie for display of cta at all: if( cookieHideCTA ) { $j(".ctaImageLink").hide(); $j(".ctaShortRegForm").show(); $j(".scfSubmitButton").removeAttr("disabled"); } else { _gaq.push(['_trackEvent', 'Registration Process', 'CTA Load', ctaValue]); //if form not submitted $j(".ctaImageLink").click(function (event) { $j(this).hide(); $j.cookie('hreghidecta','true'); $j.cookie('hregctaval',ctaValue); $j(".ctaShortRegForm").show(); _gaq.push(['_trackEvent', 'Registration Process', 'CTA Click', ctaValue]); }); } $j(".scfSubmitButton").click(function (event) { var ok = true; $j('input.scfSingleLineTextBox').each(function(){ if($j(this).val() == $j(this).data('originalValue') || $j(this).val() == ''){ ok=false; } }); if(ok){ $j.cookie('hregshowthanks','true',{expires:30,path:'/'}); _gaq.push(['_trackEvent', 'Registration Process', 'CTA Form Submit', ctaValue]); } else{ return false; } }); //make sure text box inputs have an original value set in data $j("input.scfSingleLineTextBox").each(function(){ if (!$j(this).data('originalValue')) { $j(this).data('originalValue', $j(this).val()); } }); //adjust user input $j('input.scfSingleLineTextBox').focus(function () { if (!$j(this).data('originalValue')) { $j(this).data('originalValue', $j(this).val()); } if ($j(this).val() == $j(this).data('originalValue')) { $j(this).val(''); } //simple validation $j(this).keyup(function(){ var ok = true; $j('input.scfSingleLineTextBox').each(function(){ if($j(this).val() == $j(this).data('originalValue') || $j(this).val() == ''){ $j(".scfSubmitButton").attr("disabled","disabled"); ok=false; } }); if(ok){ $j(".scfSubmitButton").removeAttr("disabled"); } }); }).blur(function () { $j(this).unbind('onkeyup') if ($j(this).val() == '') { $j(this).val($j(this).data('originalValue')); } }); } }); </script> <div id="greetingContainer2_ctlLanding_divCtaLandingContainer" class="ctaLandingContainer"> <div id="greetingContainer2_ctlLanding_divCtaImage" class="ctaImageLink"> <img src="/web/20131220232731im_/http://www.healio.com/~/media/Healio/50plus.jpg" alt="Register Now" width="220" height="112"/> </div> <div class="ctaShortRegForm" style="display: none;"> <div class="shortRegTitle"> Register Free</div> <div class="shortRegForm"> <div class="scfForm" id="form_83EA09863C65413F858E12608727AA3B"><input type="hidden" name="greetingContainer2$ctlLanding$form_83EA09863C65413F858E12608727AA3B$formreference" id="greetingContainer2_ctlLanding_form_83EA09863C65413F858E12608727AA3B_formreference" value="form_83EA09863C65413F858E12608727AA3B"/><h1 id="greetingContainer2_ctlLanding_form_83EA09863C65413F858E12608727AA3B_title" class="scfTitleBorder"> </h1> <div id="greetingContainer2_ctlLanding_form_83EA09863C65413F858E12608727AA3B_intro" class="scfIntroBorder"> </div> <div id="greetingContainer2_ctlLanding_form_83EA09863C65413F858E12608727AA3B_form_83EA09863C65413F858E12608727AA3B_submitSummary" class="scfSubmitSummary" style="color:Red;"> </div> <div 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href="/web/20131220232731/http://www.healio.com/dermatology/practice-management/news"> News</a> </p>    <div id="SeeAlso" class="related-links"> <h3>See Also</h3> <ul><li><a href="https://web.archive.org/web/20131220232731/http://www.healio.com/dermatology/practice-management/news/online/%7B1fe1a6b7-7cee-41e4-a04f-21e7cf2a526e%7D/fda-otc-topical-pain-relievers-cause-rare-cases-of-serious-burns">FDA: OTC topical pain relievers cause rare cases of serious ...</a></li><li><a href="https://web.archive.org/web/20131220232731/http://www.healio.com/dermatology/practice-management/news/online/%7Bb14b768a-ee70-4dca-b45e-08ca03edca0b%7D/fda-approves-nuvail-for-brittle-nails">FDA approves Nuvail for brittle nails</a></li><li><a href="https://web.archive.org/web/20131220232731/http://www.healio.com/dermatology/practice-management/news/online/%7B8462446b-29cb-4735-a332-a8934366d603%7D/mycophenolate-mofetil-found-effective-for-autoimmune-chronic-idiopathic-urticaria">Mycophenolate mofetil found effective for autoimmune ...</a></li></ul> </div>    <input name="layout_0$maincontent_0$seeAlsoInsertUnderParagraph" type="hidden" id="layout_0_maincontent_0_seeAlsoInsertUnderParagraph" value="1"/>  <div class="content"> <h2> FDA considers Xolair for chronic idiopathic urticaria</h2> <h3 class="deck"> </h3> <p class="main-subtitle"> </p> <div class="social-links-top"> <ul class="share"> <li class="l1"><a href="javascript:void(0)" class="facebook-link" target="_new">Facebook</a></li> <li class="l2"><a href="javascript:void(0)" class="twitter-link" target="_new">Tweet</a></li> <li class="l3"><a href="javascript:void(0)" class="linkedin-link">Share</a></li> </ul> </div> <ul class="meta-info"> <li> October 14, 2013</li> </ul> <div class="wyContent"> <p>The FDA has accepted and filed a supplemental biologics license application for the subcutaneous use of omalizumab in patients with chronic idiopathic urticaria with ongoing symptoms despite antihistamine therapy, Genentech has announced.</p> <p>The FDA’s action on <a href="https://web.archive.org/web/20131220232731/http://www.healio.com/dermatology/search?q=omalizumab%20&requiredfields=specialty:Dermatology" target="blank">omalizumab</a> (Xolair) was based on two double blind, placebo-controlled phase 3 studies in 642 patients with moderate to severe chronic idiopathic <a href="https://web.archive.org/web/20131220232731/http://www.healio.com/dermatology/search?q=urticaria&requiredfields=specialty:Dermatology" target="blank">urticaria</a> (CIU) who remained symptomatic despite treatment with H1-antihistamines, according to a <a href="https://web.archive.org/web/20131220232731/http://www.gene.com/media/press-releases/14551/2013-10-10/fda-files-genentechs-supplemental-biolog" target="blank">press release</a>. The drug’s safety profile as add-on therapy for CIU patients who remained symptomatic despite previous antihistamines was conducted in a third parallel-group trial on 336 patients.</p> <p>Genentech and Novartis Pharma AG co-market Xolair in the United States with Novartis Pharmaceuticals Corp.</p> <p>Action is expected by the FDA in the second quarter of 2014, according to the release.</p> <p>Injected subcutaneously, omalizumab is intended for patients aged 12 years and older with moderate to severe persistent allergic <a href="https://web.archive.org/web/20131220232731/http://www.healio.com/search?q=asthma" target="blank">asthma</a> whose symptoms are uncontrolled by inhaled steroids.</p> <p>Some patients receiving omalizumab experienced anaphylaxis, according to the release. Patients assigned omalizumab reported more cancers, including breast, skin, prostate and parotid, than those not assigned the drug during clinical studies.</p> <p>The most common side effects in patients assigned omalizumab compared with placebo were joint pain, general pain, leg pain, fatigue, dizziness, fractures, arm pain, itching, skin inflammation and earache.</p> <p>“We are pleased that the FDA has filed our application for Xolair for chronic idiopathic urticaria,” <strong>Hal Barron, MD</strong><strong>,</strong> chief medical officer and head of global product development, Genentech, said in the release. “We hope we can soon bring our medicine to people with this chronic form of hives.”</p> </div>  <div class="fig left"> <p class="figcaption"> </p> </div> <div class="wyPagination">   </div>  <div class="follow"> <img src="/web/20131220232731im_/http://www.healio.com/~/media/Images/News/FollowUs.jpg" id="layout_0_maincontent_1_SocialFollow_socialfollow" name="socialfollow" alt="Follow us" usemap="#followus" border="0"/> <map id="followus" name="followus"> <area id="layout_0_maincontent_1_SocialFollow_followfb" shape="rect" coords="51,5,5,51" target="_blank" href="https://web.archive.org/web/20131220232731/https://www.facebook.com/pages/Healiocom-Dermatology/428173193888632?ref=hl" alt="Follow us on Facebook"></area> <area id="layout_0_maincontent_1_SocialFollow_followtw" shape="rect" coords="270,3,320,50" target="_blank" href="https://web.archive.org/web/20131220232731/https://twitter.com/healioderm" alt="Follow us on Twitter"></area> </map> </div> </div>  <div class="social-links"> <div class="fb-like" data-send="false" data-width="300" data-show-faces="true" data-action="recommend"></div> <ul class="share"> <li><a href="javascript:void(0)" id="twitter" class="twitter-link" target="_new">Tweet</a></li> <li><a href="javascript:void(0)" id="facebook" class="facebook-link" target="_new">Share</a></li> <li class="linkedin"><a href="javascript:void(0)" id="linkedin" class="linkedin-link">Link</a></li> <li><span class="db-wrapper"><span class="g-plusone" data-size="tall" data-annotation="none"></span></span></li> <li><a href="javascript:void(0)" id="email">Email</a></li> <li class="last"><a href="javascript:void(0)" id="print">Print</a></li> </ul> <input name="layout_0$maincontent_1$SocialMedia$articleItemForTweet" type="hidden" id="layout_0_maincontent_1_SocialMedia_articleItemForTweet" value="{F1339A57-24F2-45AD-BF2C-997B76CB249B}"/> <input name="layout_0$maincontent_1$SocialMedia$tweettext" type="hidden" id="layout_0_maincontent_1_SocialMedia_tweettext" class="tweettext" value="FDA considers Xolair for chronic idiopathic urticaria "/> <input name="layout_0$maincontent_1$SocialMedia$tweeturl" type="hidden" id="layout_0_maincontent_1_SocialMedia_tweeturl" class="tweeturl" value="http://goo.gl/Jg8exT"/> </div>  <div id="respond"> <h4> Comments</h4> <script language="javascript" type="text/javascript"> var idcomments_acct = 'aa6ff53f9870e40f92f83e1b5df3cddf'; var idcomments_post_id = '{F1339A57-24F2-45AD-BF2C-997B76CB249B}'; var idcomments_post_url; </script> <span id="IDCommentsPostTitle" style="display: none"></span> <script type="text/javascript" src="https://web.archive.org/web/20131220232731js_/http://www.intensedebate.com/js/genericCommentWrapperV2.js"></script> <p class="comment-notes"> Healio is intended for health care provider use and all comments will be posted at the discretion of the editors. 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