On Friday, the FDA gave Novartis (Novartis (NVS)) the full stamp of approval for its oral drug Fabhalta (iptacopan). The drug is now officially authorized to slow the decline of kidney function in adults with primary immunoglobulin A nephropathy (IgAN) who are at high risk of their disease getting worse.

IgAN is a nasty autoimmune kidney disease. About 25 people per million get diagnosed each year globally, and for those with persistent proteinuria, up to 50% can progress to kidney failure within 10 to 20 years. That usually means dialysis or a kidney transplant. Fabhalta's goal is to slow that decline, buying patients more time before they need those interventions.

Fabhalta is a first-in-class complement inhibitor—it works by blocking Factor B in the alternative complement pathway, which helps reduce ongoing kidney injury. It first got accelerated FDA approval back in August 2024 for reducing proteinuria, but this traditional approval is based on more solid evidence from the Phase 3 APPLAUSE-IgAN trial.

That trial showed a clinically meaningful improvement in estimated glomerular filtration rate (eGFR) over two years. Patients on Fabhalta saw their eGFR decline by an average of only -3.0 mL/min/1.73 m2 per year, compared to -5.7 in the placebo group. That's a meaningful difference—slower decline means kidneys stay functional longer.

Safety-wise, Fabhalta's profile was consistent with earlier data, but there's a catch: because it can increase the risk of severe infections from encapsulated bacteria, the drug is only available through a Risk Evaluation and Mitigation Strategy (REMS) program. That means patients need to be properly vaccinated before starting therapy.

Novartis is also making sure cost isn't a barrier. The company offers financial assistance so that nearly all eligible U.S. patients can get Fabhalta for $10 or less per month. That's a smart move for a drug that could be a long-term maintenance therapy.

This approval strengthens Novartis's kidney disease portfolio. The company is also working on Vanrafia and the experimental drug zigakibart for IgAN, so Fabhalta is just one piece of a broader pipeline.

Investors seemed pleased. Novartis shares were up 1.01% at $154.28 on Friday.