Novartis just converted Fabhalta’s accelerated approval into a full one, and the timing tells you where the money’s going. The FDA’s traditional approval, granted July 16, lets Fabhalta claim it slows kidney function decline in IgA nephropathy patients at risk of progression, not just reduce proteinuria, the surrogate marker that won its 2023 speedy clearance. The upgrade rests on two-year eGFR data from the same phase 3 trial that got it in the door originally.
IgAN hits roughly 25 per million people worldwide, and up to half of those with proteinuria land on dialysis or a transplant list within 10 to 20 years. That’s a small population willing to pay a lot for a drug that buys time.
Fabhalta sales hit $505 million last year, up 291%, with another $169 million in Q1 alone. Novartis isn’t stopping there. It picked up Chinook Therapeutics for $3.2 billion upfront in 2023, landing Vanrafia, which got its own accelerated nod in April despite missing its kidney-function endpoint. A third asset, zigakibart, is in phase 3 with an eGFR readout due in early 2027.
Two drugs on the market, a third in the pipeline, and rivals Travere and Calliditas holding the rest of the field. Three assets targeting one 25-per-million indication isn’t diversification. It’s a moat.
Worth watching whether atrasentan’s full-approval bid clears the same eGFR bar Fabhalta just did.
— Rebecca Lauren