FDA Approves First Dual-Action Drug for IgA Nephropathy Kidney Disease
The U.S. Food and Drug Administration (FDA) has approved Trutakna, a new injectable drug developed by Vera Therapeutics, for treating IgA nephropathy, also known as Berger's disease. This chronic kidney condition primarily affects young people and can progress to kidney failure, requiring dialysis or transplantation. Trutakna received accelerated approval based on clinical trial results demonstrating a 42% reduction in urinary protein, a key marker of kidney damage.
Trutakna is the first therapy targeting two immune system proteins, BAFF and APRIL, which play a central role in producing the harmful antibodies that cause the disease. By reducing these antibodies, the drug aims to decrease immune activity and inflammation in the kidneys at early disease stages. The medication is now available for prescription in the U.S., with supply expected within three to four weeks.
Professor Benaya Rozen-Zvi, head of nephrology at Israel's Beilinson and Sharon Medical Centers, explained that IgA nephropathy is an autoimmune disease affecting thousands in Israel, many of whom risk progressing to kidney failure. Current treatments mainly involve steroids and supportive care, which slow but do not stop disease progression. The new drug addresses the root cause by lowering defective antibody production, improving kidney function markers, and slowing disease advancement. However, it is not a cure, as some antibody production is necessary for immune defense, and irreversible kidney damage may already exist at diagnosis.
The FDA approval was based on a late-stage study showing a 42% reduction in urinary protein after 36 weeks of treatment compared to placebo, with a 46% decrease from baseline in treated patients. Urinary protein reduction is a critical therapeutic goal, indicating less kidney damage. Ongoing research is evaluating whether this translates into better long-term kidney function, with updated results expected by the third quarter of 2026, ahead of the original 2027 schedule.
IgA nephropathy is among the most common glomerular kidney diseases worldwide, caused by IgA antibody deposits triggering inflammation and gradual kidney tissue damage. Disease progression varies, with some patients experiencing slow decline and others facing rapid kidney failure. The drug’s annual cost in the U.S. is approximately $425,000, reflecting a high price for this innovative treatment. Trutakna joins other therapies on the market but is unique in its dual inhibition of BAFF and APRIL, targeting the immune process underlying the disease.
