{"id":70165,"date":"2026-07-17T21:21:01","date_gmt":"2026-07-17T13:21:01","guid":{"rendered":"https:\/\/flcube.com\/?p=70165"},"modified":"2026-07-17T21:21:02","modified_gmt":"2026-07-17T13:21:02","slug":"novartis-fabhalta-receives-fda-approval-as-first-oral-complement-factor-b-inhibitor-to-slow-renal-decline-in-primary-iga-nephropathy","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=70165","title":{"rendered":"Novartis’ Fabhalta Receives FDA Approval as First Oral Complement Factor B Inhibitor to Slow Renal Decline in Primary IgA Nephropathy"},"content":{"rendered":"\n

Novartis AG<\/strong> (NYSE: NVS<\/a>) announced that the U.S. Food and Drug Administration (FDA) has granted regular approval for Fabhalta<\/strong> (iptacopan) to slow renal decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Iptacopan represents the world’s first-in-class oral inhibitor of complement factor B<\/strong>, with approval based on robust Phase III data demonstrating significant preservation of kidney function over two years.<\/p>\n\n\n\n

Regulatory Approval Summary<\/h2>\n\n\n\n
Component<\/th>Detail<\/th><\/tr><\/thead>
Agency<\/strong><\/td>U.S. Food and Drug Administration (FDA)<\/td><\/tr>
Product<\/strong><\/td>Fabhalta (iptacopan)<\/td><\/tr>
Approval Type<\/strong><\/td>Regular approval (not accelerated)<\/td><\/tr>
Indication<\/strong><\/td>Slowing renal decline in adults with primary IgA nephropathy at risk of progression<\/td><\/tr>
Mechanism<\/strong><\/td>First-in-class oral complement factor B inhibitor<\/td><\/tr>
Basis of Approval<\/strong><\/td>Phase III APPLAUSE-IgAN study<\/td><\/tr>
Previous Approval<\/strong><\/td>Paroxysmal nocturnal hemoglobinuria (PNH) in 2023<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Clinical Trial Results \u2013 APPLAUSE-IgAN Study<\/h2>\n\n\n\n
Endpoint<\/th>Fabhalta Group<\/th>Placebo Group<\/th>Treatment Difference<\/th><\/tr><\/thead>
Annualized eGFR Change<\/strong><\/td>-3.0 mL\/min\/1.73 m\u00b2\/year<\/td>-5.7 mL\/min\/1.73 m\u00b2\/year<\/td>+2.7 mL\/min\/1.73 m\u00b2\/year<\/strong><\/td><\/tr>
Study Duration<\/strong><\/td>24 months<\/td>24 months<\/td>Statistically significant<\/td><\/tr>
Clinical Significance<\/strong><\/td>47% reduction in rate of kidney function decline<\/td>\u2014<\/td>Clinically meaningful benefit<\/td><\/tr>
Consistency<\/strong><\/td>Superior performance across all key renal outcome measures<\/td>\u2014<\/td>Robust treatment effect<\/td><\/tr><\/tbody><\/table><\/figure>\n\n\n\n

Disease Background & Unmet Need<\/h2>\n\n\n\n