Treats paroxysmal nocturnal hemoglobinuria (PNH). NDA 218276, held by Novartis. Iptacopan Hydrochloride.
As of Nov 13, 2026, NDA 218276 (Fabhalta), held by Novartis, was first approved by FDA on Dec 5, 2023, with 5 approved supplements and 0 published complete response letters.
FABHALTA is a complement factor B inhibitor, indicated for: the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. the treatment of adults with complement 3 glomerulopathy (C3G), to reduce proteinuria. 1.1 Paroxysmal Nocturnal Hemoglobinuria FABHALTA is indicated for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH). 1.2 Immunoglobulin A Nephropathy FABHALTA is indicated to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. 1.
| Jul 16, 2026 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Mar 20, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2024 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| Dec 5, 2023 | Original applicationNew molecular entity · Priority review | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| FabhaltaEQ 200MG BASE · capsule;oral | Iptacopan Hydrochloride | RxReference drug |
| Jul 16, 2026 | Supplement 7Efficacy (new indication or use) · Priority review | Approved | |
| Mar 20, 2025 | Supplement 4Efficacy (new indication or use) · Priority review | Approved | |
| Aug 7, 2024 | Supplement 1Efficacy (new indication or use) · Priority review | Approved | |
| May 24, 2024 | Supplement 3REMS | Approved | |
| Mar 26, 2024 | Supplement 2Labeling · Standard review | Approved | |
| Dec 5, 2023 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
