Bimekizumab Under FDA Review for Hidradenitis Suppurativa

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<root generator="drupal.xsl" gversion="1.7"> <header> <fileName>167642</fileName> <TBEID>0C04F815.SIG</TBEID> <TBUniqueIdentifier>MD_0C04F815</TBUniqueIdentifier> <newsOrJournal>News</newsOrJournal> <publisherName>Frontline Medical Communications</publisherName> <storyname/> <articleType>2</articleType> <TBLocation>QC Done-All Pubs</TBLocation> <QCDate>20240411T144609</QCDate> <firstPublished>20240411T153147</firstPublished> <LastPublished>20240411T153147</LastPublished> <pubStatus qcode="stat:"/> <embargoDate/> <killDate/> <CMSDate>20240411T153147</CMSDate> <articleSource/> <facebookInfo/> <meetingNumber/> <byline>Doug Brunk</byline> <bylineText>DOUG BRUNK</bylineText> <bylineFull>DOUG BRUNK</bylineFull> <bylineTitleText/> <USOrGlobal/> <wireDocType/> <newsDocType>News</newsDocType> <journalDocType/> <linkLabel/> <pageRange/> <citation/> <quizID/> <indexIssueDate/> <itemClass qcode="ninat:text"/> <provider qcode="provider:imng"> <name>IMNG Medical Media</name> <rightsInfo> <copyrightHolder> <name>Frontline Medical News</name> </copyrightHolder> <copyrightNotice>Copyright (c) 2015 Frontline Medical News, a Frontline Medical Communications Inc. company. All rights reserved. This material may not be published, broadcast, copied, or otherwise reproduced or distributed without the prior written permission of Frontline Medical Communications Inc.</copyrightNotice> </rightsInfo> </provider> <abstract/> <metaDescription>Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) to review bimekizumab-bkzx, an interleukin (IL)-17A and IL-17F i</metaDescription> <articlePDF/> <teaserImage/> <title>Bimekizumab Under FDA Review for Hidradenitis Suppurativa</title> <deck/> <disclaimer/> <AuthorList/> <articleURL/> <doi/> <pubMedID/> <publishXMLStatus/> <publishXMLVersion>1</publishXMLVersion> <useEISSN>0</useEISSN> <urgency/> <pubPubdateYear/> <pubPubdateMonth/> <pubPubdateDay/> <pubVolume/> <pubNumber/> <wireChannels/> <primaryCMSID/> <CMSIDs/> <keywords/> <seeAlsos/> <publications_g> <publicationData> <publicationCode>skin</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>im</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> <publicationData> <publicationCode>fp</publicationCode> <pubIssueName/> <pubArticleType/> <pubTopics/> <pubCategories/> <pubSections/> </publicationData> </publications_g> <publications> <term canonical="true">13</term> <term>21</term> <term>15</term> </publications> <sections> <term canonical="true">39313</term> <term>37225</term> </sections> <topics> <term canonical="true">39212</term> <term>203</term> </topics> <links/> </header> <itemSet> <newsItem> <itemMeta> <itemRole>Main</itemRole> <itemClass>text</itemClass> <title>Bimekizumab Under FDA Review for Hidradenitis Suppurativa</title> <deck/> </itemMeta> <itemContent> <p>On April 4, 2024, the US <span class="tag metaDescription">Food and Drug Administration (FDA) accepted a supplemental Biologics License Application (sBLA) to review bimekizumab-bkzx, an interleukin (IL)-17A and IL-17F inhibitor, for the treatment of adults with moderate to severe hidradenitis suppurativa (HS)</span>.</p> <p>The agency also accepted a second sBLA for a bimekizumab-bkzx 2-mL device.<br/><br/>The developments were announced in a <a href="https://www.ucb.com/stories-media/Press-Releases/article/FDA-Accepts-Supplemental-Biologics-License-Applications-for-BIMZELXR-bimekizumab-bkzx-for-Moderate-to-Severe-Hidradenitis-Suppurativa-and-Additional-2mL-Device-Presentations">press release</a> from UCB, the manufacturer of bimekizumab-bkzx (Bimzelx), which was <a href="https://www.medscape.com/viewarticle/997490">first approved</a> in the United States in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.<br/><br/>According to the press release, acceptance of the sBLA was based on results from two phase 3 studies known as <a href="https://clinicaltrials.gov/study/NCT04242446?cond=Hidradenitis%20Suppurativa&amp;term=Be%20HEARD%20&amp;rank=1">BE HEARD I</a> and <a href="https://clinicaltrials.gov/study/NCT04242498?cond=Hidradenitis%20Suppurativa&amp;term=Be%20HEARD%20&amp;rank=2">BE HEARD II</a>, which found that bimekizumab-bkzx showed clinically meaningful improvements compared with placebo at week 16 and were sustained to week 48. If approved, this would be the first HS approval for bimekizumab-bkzx worldwide. In the European Union, it is approved for treating adults with psoriatic arthritis and axial spondyloarthritis, in addition to moderate to severe psoriasis.<br/><br/>According to the company, approval of the 2-mL injection device would mean that patients would have an alternative one-injection regimen option; currently, one dose for psoriasis is administered as two 1-mL injections. Full US prescribing information for bimekizumab-bkzx can be found <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761151s000lbl.pdf">here</a>.<span class="end"/></p> <p> <em>A version of this article first appeared on <span class="Hyperlink"><a href="https://www.medscape.com/viewarticle/company-seeks-approval-bimekizumab-hidradenitis-suppurativa-2024a10006h2?src=">Medscape.com</a></span>.</em> </p> </itemContent> </newsItem> <newsItem> <itemMeta> <itemRole>teaser</itemRole> <itemClass>text</itemClass> <title/> <deck/> </itemMeta> <itemContent> <p>Bimekizumab-bkzx was first approved in the United States in October 2023 for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.</p> </itemContent> </newsItem> </itemSet></root>