{"id":551,"date":"2026-08-23T08:14:02","date_gmt":"2026-08-23T08:14:02","guid":{"rendered":"https:\/\/noimfine.com\/sph06\/?p=551"},"modified":"2026-09-23T08:14:54","modified_gmt":"2026-09-23T08:14:54","slug":"voyxact-fda-grants-accelerated-approval-to-once-monthly-injection-for-adults-with-iga-nephropathy-2","status":"publish","type":"post","link":"https:\/\/noimfine.com\/sph06\/2026\/08\/23\/voyxact-fda-grants-accelerated-approval-to-once-monthly-injection-for-adults-with-iga-nephropathy-2\/","title":{"rendered":"Voyxact: FDA Grants Accelerated Approval to Once-Monthly Injection for Adults With IgA Nephropathy"},"content":{"rendered":"<div><!--[--><!--&gt;--><\/p>\n<div>\n<div>\n<div>\n<div><\/div>\n<\/div>\n<\/div>\n<\/div>\n<div>\n<div>\n<section><a href=\"https:\/\/www.webmd.com\/drugs\/voyxact-sibeprenlimab-szsi\">Voyxact (sibeprenlimab-szsi)<\/a> is a new medicine approved by the FDA to lower protein levels in urine for adults with a kidney condition called primary immunoglobulin A nephropathy (IgAN) who are at risk of their illness getting worse.<iframe src=\"https:\/\/www.youtube.com\/embed\/rkBMQdVmFMo\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>IgAN is a long-lasting illness caused by the buildup of a type of antibody called IgA in the kidneys.<iframe src=\"https:\/\/www.youtube.com\/embed\/tER0olM0LXU\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>This buildup causes inflammation and damage, leading to protein in the urine (proteinuria) and a gradual decline in kidney function.<iframe src=\"https:\/\/www.youtube.com\/embed\/3m4mGL3DeHA\" width=\"560\" height=\"315\" frameborder=\"0\" allowfullscreen=\"allowfullscreen\"><\/iframe><\/p>\n<p>If left untreated, IgAN can lead to kidney failure. Voyxact is a lab-made monoclonal antibody that works by blocking a protein called A proliferation-inducing ligand (APRIL). APRIL produces a harmful type of IgA called galactose-deficient IgA1 (Gd-IgA1), which plays a major role in the development of IgAN. By blocking APRIL, Voyxact lowers Gd-IgA1 levels in the blood and helps protect the kidneys from further damage. This approval matters because Voyxact is the first medicine approved by the FDA that directly targets APRIL, providing a new option for adults with IgAN who are at risk of their disease getting worse.<\/section>\n<section>\n<h2>Why Was It Approved?<\/h2>\n<p>The FDA has granted accelerated approval to Voyxact based on interim results from an ongoing phase III clinical trial. In this study, Voyxact significantly lowered protein levels in the urine \u2014 a sign of kidney damage \u2014 in adults with confirmed IgAN who were already on standard supportive treatments. Among the first 320 patients in the study analyzed, those treated with Voyxact showed about a 50% decrease in their urinary protein level after nine months, while a 2% increase in proteinuria was observed in the placebo group. Voyxact also lowered levels of other biological markers associated with disease activity, such as, reducing APRIL levels by 95.8% and pathogenic Gd-IgA1 levels by 67.1% at week 48. Even though the drop in protein levels is promising, it\u2019s not yet clear if Voyxact can protect kidney function over the long term. Because of this, the FDA\u2019s approval is conditional. For the continued approval of this treatment, the manufacturing company must do more follow-up studies to confirm and clearly show that the medicine provides lasting clinical benefits. The most common side effects are upper respiratory tract infections and redness at the injection site.<\/section>\n<\/div>\n<div>\n<section>\n<h2>What Do I Need to Know?<\/h2>\n<p>Voyxact comes in a prefilled syringe and can be given at home after you or your caregiver are trained. It is given as a shot once every four weeks under the skin in the thighs or the abdomen (stomach area), avoiding the area 2 inches around the belly button. A caregiver may inject it in the back of your upper arm. If you miss a dose, take it as soon as you remember and then return to your regular four-week schedule. Don\u2019t use Voyxact if you\u2019ve had a serious allergic reaction to it or any of its ingredients. Before starting the treatment, your health care provider will check for any active infections since Voyxact lowers your immune system\u2019s ability to make antibodies, which can increase your risk for infections. You should not get live vaccines within 30 days of starting or while using this medicine since it can affect vaccine responses and worsen their risks. Inform your health care provider <a>if you have an infection,\u00a0<\/a>are getting treated for an infection, or have an infection that doesn\u2019t go away or keeps coming back<a>.\u00a0<\/a>Be sure to share your vaccination schedule and a full list of everything you take, including prescription medicines, medicines or therapies that can suppress your immune system (immunosuppressive therapy), over-the-counter medicines, vitamins, and herbal supplements, to avoid possible interactions.<\/section>\n<section>Let your health care provider know if you are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed because it\u2019s not yet known whether the medicine could affect your baby. Contact your health care provider right away if you notice any signs of infection, such as fever, chills, flu-like symptoms, cough, muscle aches, or red or painful skin, or signs of allergic reaction, such as swelling of the face, lips, or throat; trouble breathing; itching; hives; or skin rash.<\/section>\n<\/div>\n<\/div>\n<p><!--&gt;<\/div>\n\n\n--><\/div>\n","protected":false},"excerpt":{"rendered":"<p>Voyxact (sibeprenlimab-szsi) is a new medicine approved by the FDA to lower protein levels in urine for adults with a kidney condition called primary immunoglobulin A nephropathy (IgAN) who are at risk of their illness getting worse. IgAN is a&#8230; <\/p>\n","protected":false},"author":2,"featured_media":385,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-551","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/551","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/comments?post=551"}],"version-history":[{"count":1,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/551\/revisions"}],"predecessor-version":[{"id":552,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/posts\/551\/revisions\/552"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/media\/385"}],"wp:attachment":[{"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/media?parent=551"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/categories?post=551"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/noimfine.com\/sph06\/wp-json\/wp\/v2\/tags?post=551"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}