SWX:NOVNPharmaceuticals
Does Full Fabhalta Approval in IgA Nephropathy Reshape the Bull Case for Novartis (SWX:NOVN)?
Earlier this month, Novartis received traditional FDA approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy at risk of disease progression, upgrading its earlier accelerated approval that was based on proteinuria reduction.
The decision is grounded in two-year Phase III data showing Fabhalta’s first-in-class oral complement inhibition meaningfully slowed estimated glomerular filtration rate decline versus placebo, reinforcing...