{"id":5579,"date":"2025-07-09T11:59:00","date_gmt":"2025-07-09T11:59:00","guid":{"rendered":"https:\/\/www.dovegelpacks.com\/?p=5579"},"modified":"2025-09-16T09:35:16","modified_gmt":"2025-09-16T09:35:16","slug":"novartis-receives-approval-for-first-malaria-medicine-for-newborn-babies-and-young-infants","status":"publish","type":"post","link":"https:\/\/www.dovegelpacks.com\/?p=5579","title":{"rendered":"Novartis receives approval for first malaria medicine for newborn babies and young infants"},"content":{"rendered":"<figure class=\"wp-block-image size-full\"><img fetchpriority=\"high\" decoding=\"async\" width=\"1200\" height=\"360\" src=\"https:\/\/www.dovegelpacks.com\/wp-content\/uploads\/2025\/07\/news-image-7.webp\" alt=\"\" class=\"wp-image-5747\" srcset=\"https:\/\/www.dovegelpacks.com\/wp-content\/uploads\/2025\/07\/news-image-7.webp 1200w, https:\/\/www.dovegelpacks.com\/wp-content\/uploads\/2025\/07\/news-image-7-300x90.webp 300w, https:\/\/www.dovegelpacks.com\/wp-content\/uploads\/2025\/07\/news-image-7-1024x307.webp 1024w, https:\/\/www.dovegelpacks.com\/wp-content\/uploads\/2025\/07\/news-image-7-768x230.webp 768w, https:\/\/www.dovegelpacks.com\/wp-content\/uploads\/2025\/07\/news-image-7-600x180.webp 600w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/><\/figure><ul class=\"wp-block-list\"><li><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ast-global-color-0-color\">Coartem<\/mark><\/em><sup><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ast-global-color-0-color\"><em>\u00ae<\/em><\/mark><\/sup><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ast-global-color-0-color\">&nbsp;(artemether-lumefantrine) Baby becomes first malaria treatment approved for newborn babies and young infants<\/mark><\/em><\/li>\n\n<li><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ast-global-color-0-color\">Rapid approvals in eight African countries now expected under a special global health scheme run by Swiss agency for therapeutic products (Swissmedic)<\/mark><\/em><\/li>\n\n<li><em><mark style=\"background-color:rgba(0, 0, 0, 0)\" class=\"has-inline-color has-ast-global-color-0-color\">Novartis plans to introduce infant-friendly Coartem Baby on largely not-for-profit basis to increase access in areas where malaria is endemic<\/mark><\/em><\/li><\/ul><p class=\"wp-block-paragraph\">Novartis announced Coartem<sup>\u00ae<\/sup>&nbsp;(artemether-lumefantrine) Baby has been approved by Swissmedic as the <a href=\"https:\/\/www.dovegelpacks.com\/novartis-receives-approval-for-first-malaria-medicine-for-newborn-babies-and-young-infants\/\" title=\"\"><mark style=\"background-color:rgba(0, 0, 0, 0);color:#f78da7\" class=\"has-inline-color\">first malaria medicine for newborns <\/mark><\/a>and young infants. The new treatment, also known as Riamet<sup>\u00ae<\/sup>&nbsp;Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV) to treat the potentially deadly mosquito-borne disease.<\/p><p class=\"wp-block-paragraph\">Eight African countries also participated in the assessment and are now expected to issue rapid approvals under the Swiss agency\u2019s Marketing Authorization for Global Health Products procedure.<sup>1<\/sup>&nbsp;Novartis plans to introduce the infant-friendly treatment on a largely not-for-profit basis to increase access in areas where malaria is endemic.<\/p><p class=\"wp-block-paragraph\">\u201cFor more than three decades, we have stayed the course in the fight against malaria, working relentlessly to deliver scientific breakthroughs where they are needed most,\u201d said Vas Narasimhan, CEO of Novartis. \u201cTogether with our partners, we are proud to have gone further to develop the first clinically proven malaria treatment for newborns and young babies, ensuring even the smallest and most vulnerable can finally receive the care they deserve.\u201d<\/p><p class=\"wp-block-paragraph\">Until now, there has been no approved malaria treatment for infants weighing less than 4.5 kilograms, leaving a treatment gap. They have instead been treated with formulations intended for use in older children, which may increase the risk of overdose and toxicity. Malaria vaccines are also not approved for the youngest babies.<sup>2<\/sup><\/p><p class=\"wp-block-paragraph\">Some 30 million babies are born in areas of malaria risk in Africa every year,<sup>3<\/sup>&nbsp;with one large survey across West Africa reporting infections ranging between 3.4% and 18.4% in infants younger than 6 months old.However, current data on malaria in young babies is extremely limited as they are rarely included in clinical trials of antimalarial agents.<sup>5,6<\/sup><\/p><p class=\"wp-block-paragraph\">\u201cThe available malaria treatments have only been properly tested in children aged at least 6 months because smaller infants are usually excluded from treatment trials,\u201d said Professor Umberto D&#8217;Alessandro, Director of the MRC Unit, The Gambia at the London School of Hygiene and Tropical Medicine. \u201cThat matters because neonates and young infants have immature liver function and metabolize some medicines differently, so the dose for older children may not be appropriate for small babies.\u201d<\/p><p class=\"wp-block-paragraph\">The new dose strength designed for young infants was developed by <mark style=\"background-color:rgba(0, 0, 0, 0);color:#abb8c3\" class=\"has-inline-color\"><a href=\"https:\/\/www.novartis.com\/\" title=\"\">Novartis<\/a> <\/mark>with the scientific and financial support of MMV, and as part of the\u202fPAMAfrica consortium, which is co-funded by the&nbsp;European &amp; Developing Countries Clinical Trials Partnership&nbsp;and the&nbsp;Swedish International Development Cooperation Agency. The treatment is dissolvable, including in breast milk, and has a sweet cherry flavor to make it easier to administer.&nbsp;<\/p><p class=\"wp-block-paragraph\">\u201cMalaria is one of the world\u2019s deadliest diseases, particularly among children. But with the right resources and focus, it can be eliminated,\u201d said Martin Fitchet, CEO of MMV. \u201cThe approval of Coartem Baby provides a necessary medicine with an optimized dose to treat an otherwise neglected group of patients and offers a valuable addition to the antimalarial toolbox.\u201d<\/p><p class=\"wp-block-paragraph\"><\/p>","protected":false},"excerpt":{"rendered":"<p>Novartis announced Coartem\u00ae&nbsp;(artemether-lumefantrine) Baby has been approved by Swissmedic as the first malaria medicine for newborns and young infants. The new treatment, also known as Riamet\u00ae&nbsp;Baby in some countries, was developed in collaboration with Medicines for Malaria Venture (MMV) to treat the potentially deadly mosquito-borne disease. Eight African countries also participated in the assessment and <a class=\"read-more-link\" href=\"https:\/\/www.dovegelpacks.com\/?p=5579\">Read More<\/a><\/p>\n","protected":false},"author":5,"featured_media":5747,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-4)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"categories":[164],"tags":[],"class_list":["post-5579","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-blog"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=\/wp\/v2\/posts\/5579","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=\/wp\/v2\/users\/5"}],"replies":[{"embeddable":true,"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=5579"}],"version-history":[{"count":0,"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=\/wp\/v2\/posts\/5579\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=\/wp\/v2\/media\/5747"}],"wp:attachment":[{"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=5579"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=5579"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.dovegelpacks.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=5579"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}