United States: Novartis has received special approval from the FDA for a new medicine called Fabhalta. This drug is used to help people with a rare kidney disease called IgA nephropathy (IgAN). Fabhalta helps reduce the amount of protein in the urine, which is a basically a sign of kidney trouble.
Study Results and Approval
As reported by Reuters, the approval was based on a study where Fabhalta showed it could lower protein levels by 44% after nine months compared to no treatment. This study involved 518 adults with IgAN and checked how well Fabhalta works and how safe it is over two years.
Secondary endpoints include urine protein-to-creatinine ratio reduction, composite kidney failure events and changes in fatigue levels.
Continued approval depends on further evidence of clinical benefit, with final study results expected in 2025.
Ongoing Development
The APPLAUSE-IgAN study’s interim analysis is focused on proteinuria reduction, a key marker of kidney damage. Fabhalta demonstrated a significant 38% reduction in proteinuria compared to placebo.
Which also includes the patients on stable doses of renin-angiotensin system inhibitors, with or without sodium-glucose cotransporter-2, and Fabhalta’s safety profile was consistent with previous findings.
Novartis is also developing two additional IgAN therapies, atrasentan and zigakibart, in late-stage trials.
Company Statement
Novartis US president Victor Bultó stated: “Today’s approval of Fabhalta as a first-in-class medicine for IgA nephropathy is an important milestone in our journey to evolve rare renal disease care by bringing new treatments to people in urgent need of options.
“We are deeply committed to those living with rare renal diseases and look forward to continued partnership with this community as we further advance our broad portfolio.”
Atrasentan has received FDA filing acceptance, and zigakibart is currently in Phase III development.
“US FDA approves Novartis’ Fabhalta in IgAN treatment” was originally created and published by Pharmaceutical Technology, a Global Data owned brand.
