{"id":91165,"date":"2026-05-06T01:03:34","date_gmt":"2026-05-06T01:03:34","guid":{"rendered":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-approves-asceniv-for-children-with-primary-humoral-immunodeficiency\/"},"modified":"2026-05-06T01:03:34","modified_gmt":"2026-05-06T01:03:34","slug":"fda-approves-asceniv-for-children-with-primary-humoral-immunodeficiency","status":"publish","type":"post","link":"https:\/\/diyhaven858.wasmer.app\/index.php\/fda-approves-asceniv-for-children-with-primary-humoral-immunodeficiency\/","title":{"rendered":"FDA approves Asceniv for children with primary humoral immunodeficiency"},"content":{"rendered":"<p> <br \/>\n<\/p>\n<div data-component=\"ArticleContent\">\n<div class=\"article__below-title\">\n<div class=\"mobile-trust-box\">\n<div class=\"row\">\n<div class=\"col-12 col-md-6 offset-md-1 offset-xl-0 col-xl-12\">\n<div class=\"email-alert-button-wrapper d-none\" data-component=\"EmailTopicAlert\" data-module=\"Subspecialty Email Topic Alerts Top\" data-manage-email-link=\"\/footer\/account-information\/my-account\/email-subscriptions-and-alerts#emailAlerts\">\n  <hidden data-setting-item=\"d265901d-6d37-49c7-a8f6-c7bf19a02509\"\/><br \/>\n  <hidden data-crm-source=\"Subspecialty Topic Alert\"\/><\/p>\n<div class=\"email-alert-button d-none\" data-topic-button=\"not-subscribed\">\n<p>&#13;<br \/>\n      <span data-module-track-action=\"Email Alerts TOP_Click_Healio News Article\" data-module-track-label=\"Email Alerts TOP_Healio News Article\">&#13;<br \/>\n        <i class=\"fas fa-plus-circle\"\/>&#13;<br \/>\n        Add topic to email alerts&#13;<br \/>\n      <\/span>&#13;\n    <\/p>\n<div class=\"email-alert-inner collapse u4e39f837a81d4aafb5ca98c25d704697\">\n<div class=\"email-alert-dialogue\">\n<p>&#13;<br \/>\n          Receive an email when new articles are posted on <span data-content=\"topic-title\"\/>&#13;\n        <\/p>\n<div class=\"d-none\" data-sign-up-type=\"unknown\">\n          Please provide your email address to receive an email when new articles are posted on <span data-content=\"topic-title\"\/>.<\/p><\/div>\n<\/p><\/div>\n<p>      <button type=\"button\" class=\"btn btn-primary\" data-loading-text=\"Loading &lt;i class=\" fa=\"\" fa-spinner=\"\" fa-spin=\"\">&#8220;&#13;<br \/>\n              data-action=&#8221;subscribe&#8221;&gt;&#13;<br \/>\n        Subscribe&#13;<br \/>\n      <\/button>\n    <\/div>\n<\/p><\/div>\n<div class=\"d-none\" data-topic-modal=\"failed\">    <strong>We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.<\/strong>  <\/p>\n<p><button data-dismiss=\"modal\" class=\"btn btn-primary btn-lg btn-block\">Back to Healio<\/button><\/p>\n<\/div>\n<\/div><\/div>\n<\/p><\/div>\n<\/p><\/div>\n<\/div>\n<p>The FDA approved a supplemental biologics license application for Asceniv, expanding its use to younger patients with primary humoral immunodeficiency, according to a press release.<\/p>\n<p>Prior to this approval, the release noted that the prescribing information for Asceniv (ADMA Biologics), a plasma-derived, polyclonal, intravenous immunoglobulin therapy, said it was only available for patients with primary humoral immunodeficiency aged at least 12 years. Now, it is available for patients aged at least 2 years.<\/p>\n<figure class=\"figure article__og-image\">&#13;\n    <picture>&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_product_healio_23007093.webp?w=476\" media=\"(max-width: 768px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_product_healio_23007093.webp?w=800\" media=\"(max-width: 992px)\">&#13;<source srcset=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_product_healio_23007093.webp?w=595\" media=\"(max-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_product_healio_23007093.webp?w=476\" media=\"(min-width: 1200px)\">&#13;<source srcset=\"https:\/\/www.healio.comhttps:\/\/www.healio.comhttps:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_product_healio_23007093.webp?w=476\">&#13;<br \/>\n&#13;<br \/>\n      <img decoding=\"async\" src=\"https:\/\/www.healio.com\/~\/media\/slack-news\/stock-images\/rheumatology\/f\/fda_product_healio_23007093.jpg?w=800\" alt=\"Image: Healio\" class=\"figure-img img-fluid\" width=\"800\"\/>&#13;<br \/>\n    <\/source><\/source><\/source><\/source><\/source><\/picture>&#13;<figcaption class=\"figure-caption\">&#13;<br \/>\n      Asceniv is now available for use in patients with primary humoral immunodeficiency aged at least 2 years, according to a press release.<br \/>&#13;<br \/>\n    <\/figcaption>&#13;<br \/>\n  <\/figure>\n<p>Asceniv first received FDA approval in April 2019, according to the release.<\/p>\n<div class=\"mug left\"><img decoding=\"async\" src=\"https:\/\/m3.healio.com\/~\/media\/slack-news\/allergy_asthma\/mugs\/w\/williams_kelli_2026.jpg\" style=\"width: 80px; height: 106px;\"\/><\/p>\n<p><strong><b>Kelli Williams<\/b><\/strong><\/p>\n<\/div>\n<p>\u201cRespiratory viruses, especially RSV, have significant impact on our pediatric patients, particularly those with primary immunodeficiency (PI),\u201d <b>Kelli Williams<\/b><b>, MD, MPH<\/b><b>,<\/b> section chief of pediatric allergy at Medical University of South Carolina, said in an email statement. \u201cThis often leads to ER visits, hospitalizations, missed school days and missed workdays for parents.<\/p>\n<p>\u201cThis new pediatric indication for Asceniv is exciting as it will offer a new treatment option for kids with PI that may improve their quality of life,\u201d she said.<\/p>\n<div class=\"article__content--footer\">\n<div class=\"sources-references-disclosures\">\n<h3>Sources\/Disclosures<\/h3>\n<h2> Source: <\/h2>\n<p class=\"citation\">&#13;<br \/>\n  Press Release&#13;\n<\/p>\n<div class=\"disclosures\">\n<p>&#13;<br \/>\n        <strong> Disclosures: <\/strong>&#13;<br \/>\n        Williams reports receiving research\/clinical trial support from ADMA Biologics, AstraZeneca, Cogent Biosciences, GlaxoSmithKline and Pharming Healthcare; 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