{"id":104626,"date":"2026-07-17T12:16:10","date_gmt":"2026-07-17T12:16:10","guid":{"rendered":"https:\/\/www.europesays.com\/ch\/104626\/"},"modified":"2026-07-17T12:16:10","modified_gmt":"2026-07-17T12:16:10","slug":"novartis-swxnovn-wins-full-fda-nod-for-fabhalta-and-wider-eu-itvisma-use","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ch\/104626\/","title":{"rendered":"Novartis (SWX:NOVN) Wins Full FDA Nod For Fabhalta And Wider EU Itvisma Use"},"content":{"rendered":"\n

Make better investment decisions<\/a> with Simply Wall St’s easy, visual tools that give you a competitive edge. <\/p>\n

Novartis (SWX:NOVN) received traditional FDA approval for Fabhalta to slow kidney function decline in adults with primary IgA nephropathy, supported by pivotal phase III data. <\/p>\n

The company also secured expanded EU approval for its gene therapy onasemnogene abeparvovec, marketed as Itvisma, to cover a broader group of spinal muscular atrophy patients. <\/p>\n

These regulatory decisions arrive with Novartis shares at CHF123.26 and a value score of 5, providing investors with fresh product news alongside current pricing metrics. The stock is reported as up 13.6% year to date and 36.1% over the past year, with a 58.3% return over three years and 86.6% over five years. <\/p>\n

For investors tracking rare disease exposure, these approvals extend the Novartis portfolio into areas with high unmet medical need. The expanded labels also add new reference points for assessing the breadth of the company’s late stage pipeline and potential launch profile without relying solely on headline revenue figures. <\/p>\n

Stay updated on the most important news stories for Novartis<\/a> by adding it to your watchlist<\/a> or portfolio<\/a>. Alternatively, explore our Community<\/a> to discover new perspectives on Novartis. <\/p>\n

\"SWX:NOVN<\/a> SWX:NOVN Earnings & Revenue Growth as at Jul 2026 <\/p>\n

4 things going right for Novartis that this headline doesn’t cover.<\/a> <\/p>\n

For Novartis, the traditional FDA approval for Fabhalta and the wider EU label for Itvisma both speak directly to the rare-disease market opportunity investors often focus on. Fabhalta moves from an earlier accelerated approval to full approval to slow kidney function decline in primary IgA nephropathy, backed by Phase III data showing a smaller annual drop in eGFR versus placebo. That gives Novartis a differentiated oral option in complement-mediated kidney disease, an area where competitors such as AstraZeneca and Roche are also active with renal and immunology portfolios. In parallel, the broader Itvisma indication across children, adolescents and adults with 5q spinal muscular atrophy in the EU positions Novartis in a wider gene-therapy pool that includes Biogen and Roche. Together, these decisions expand the addressable patient base for two high-complexity therapies, which investors may view as incremental support for Novartis’ focus on advanced platforms such as complement inhibition and gene therapy. <\/p>\n

How This Fits Into The Novartis Narrative <\/p>\n

The approvals reinforce the narrative that Novartis’ advanced-therapy pipeline can support long-term product breadth, particularly in rare kidney disease and neuromuscular conditions. <\/p>\n

REMS requirements and infection risks with Fabhalta, along with complex gene-therapy delivery and pricing questions for Itvisma, highlight the regulatory and reimbursement pressures already cited as key long-term threats. <\/p>\n

The wider SMA population for Itvisma and Fabhalta’s expansion beyond initial accelerated approval add product-specific detail that is not fully captured in high-level references to “advanced therapies” in the narrative. <\/p>\n

Knowing what a company is worth starts with understanding its story. Check out one of the top narratives in the Simply Wall St Community for Novartis<\/a> to help decide what it’s worth to you. <\/p>\n

The Risks and Rewards Investors Should Consider <\/p>\n

\u26a0\ufe0f Fabhalta’s REMS program and higher risk of serious infections from encapsulated bacteria could limit real world uptake or lead to closer safety scrutiny. <\/p>\n

\u26a0\ufe0f High-cost gene therapies like Itvisma may face tight reimbursement conditions in Europe, adding to the pricing pressure analysts already highlight for Novartis. <\/p>\n

\ud83c\udf81 Traditional approval for Fabhalta in IgA nephropathy creates a more durable commercial footing in a rare disease area with few oral options. <\/p>\n

\ud83c\udf81 Expanded EU approval for Itvisma opens a larger treated SMA population, supporting the company’s positioning in gene therapy against peers such as Biogen and Roche. <\/p>\n

What To Watch Going Forward <\/p>\n

Investors should watch how quickly Fabhalta is adopted in IgA nephropathy once physicians adjust to the REMS requirements and vaccination protocols, and whether safety outcomes stay consistent with the Phase III data. For Itvisma, the key signals will be reimbursement decisions and real world usage across older SMA patients, where treatment patterns may differ from early childhood intervention. Competitive responses from large pharma peers in both complement-mediated kidney disease and SMA will also shape how differentiated these therapies remain over time. <\/p>\n

To ensure you’re always in the loop on how the latest news impacts the investment narrative for Novartis, head to the community page for Novartis<\/a> to never miss an update on the top community narratives. <\/p>\n

This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. <\/p>\n

Companies discussed in this article include NOVN.SW<\/a>. <\/p>\n

Have feedback on this article? Concerned about the content? Get in touch<\/a> with us directly. Alternatively, email editorial-team@simplywallst.com<\/a> <\/p>\n","protected":false},"excerpt":{"rendered":"Make better investment decisions with Simply Wall St’s easy, visual tools that give you a competitive edge. Novartis…\n","protected":false},"author":2,"featured_media":104627,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_share_on_mastodon":"0"},"categories":[127],"tags":[51450,2991,212,8512,2361,6668,6646,206,5113,51449,9913],"class_list":["post-104626","post","type-post","status-publish","format-standard","has-post-thumbnail","category-novartis","tag-accelerated-approval","tag-fda-approval","tag-gene-therapy","tag-iga-nephropathy","tag-investment-decisions","tag-kidney-disease","tag-kidney-function","tag-novartis","tag-rare-disease","tag-regulatory-decisions","tag-spinal-muscular-atrophy"],"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ch\/116935274182643022","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/104626","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/comments?post=104626"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/posts\/104626\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media\/104627"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/media?parent=104626"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/categories?post=104626"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ch\/wp-json\/wp\/v2\/tags?post=104626"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}