Novartis receives FDA approval for Fabhalta to treat IgA nephropathy
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Key takeaways:
- The FDA has granted accelerated approval for Fabhalta to treat proteinuria in patients with primary IgA nephropathy.
- In phase 3 trials, the treatment achieved a 44% reduction in proteinuria from baseline.
The FDA has granted accelerated approval for Fabhalta to treat proteinuria in patients with primary IgA nephropathy, according to a press release.
Novartis has been evaluating the efficacy and safety of Fabhalta (iptacopan, Novartis) “as a twice-daily oral treatment [vs.] placebo in adult patients with primary IgA nephropathy (IgAN), on a stable dose of maximally tolerated renin-angiotensin system (RAS) inhibitor therapy with or without a stable dose of SGLT2 inhibitors,” according to the release. “Fabhalta achieved a 44% reduction in proteinuria at 9 months relative to baseline, compared with a 9% reduction in the placebo arm, demonstrating a clinically meaningful and statistically significant 38% reduction vs. placebo (P < .0001),” according to the release.
“The treatment effect on [urine protein-creatinine ratio] UPCR at 9 months was consistent across all subgroups, including age, sex, race and baseline disease characteristics(such as baseline eGFR and proteinuria levels), and the use of SGLT2 [inhibitors].”
The Applause-IgAN trial did not establish whether iptacopan slows kidney function decline in patients with IgAN, according to the release. Novartis wrote that the continued approval of the treatment “may be contingent upon verification and description of clinical benefit from the ongoing phase 3 Applause-IgAN study, evaluating whether Fabhalta slows disease progression as measured by (eGFR) decline over 24 months.
“The eGFR data are expected at study completion in 2025 and are intended to support traditional FDA approval,” the company wrote in the release.
“The heterogeneous and progressive nature of IgA nephropathy has made it challenging to effectively treat this disease. Thankfully, the treatment landscape is rapidly evolving,” Dana V. Rizk, MD, an investigator, Applause-IgAN steering committee member and professor in the division of nephrology at theUniversity of Alabama, said in the release. “Mounting clinical evidence underscores the pivotal role of complement activation in IgA nephropathy. I am thrilled that this advancement is now available to help enable a targeted treatment approach for IgAN patients.”
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