Accelerated FDA approval for kidney drug

Congratulations to Ram Sasisekharan on the accelerated FDA approval of the drug sibeprenlimab for treating IgA nephropathy (IgAN), a disease where the build-up of abnormal antibodies impedes the kidney’s ability to filter wastes and often leads to kidney damage and failure. Based on work in the Sasisekharan lab and developed by MIT spin-out Visterra (later acquired by the pharmaceutical company Otsuka), the new drug halves the amount of protein present in urine by targeting a ligand known as APRIL. Continued approval depends on trial data confirming the drug slows the decline of kidney function, due in early 2026.