Novel Drugs & Therapeutics |
Novartis presents the results of the pre-specified interim analysis of the Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan), for the treatment of patients with IgA nephropathy (IgAN)
Published on MedED: 17 April 2024
Originally published: 15 April 2024
Source: PR Newswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN001
Category: Nephrology
Crossreference: IgA Nephropathy
Category tags:Fabhalta, FactorB inhitiro, IgA Nephropathy, IgAN
Originally published: 15 April 2024
Source: PR Newswire
Type of article: Novel Drug & Emergent Therapy News
MedED Catalogue Reference: MNDN001
Category: Nephrology
Crossreference: IgA Nephropathy
Category tags:Fabhalta, FactorB inhitiro, IgA Nephropathy, IgAN
| Product Category | Product Name | Company | Status |
|---|---|---|---|
| Phase 3 Study |
April 15, 2024/PRNewswire/-Novartis
Novartis has unveiled interim results from the Phase III APPLAUSE-IgAN study of Fabhalta® (iptacopan), an investigational Factor B inhibitor of the alternative complement pathway, in patients with IgA nephropathy (IgAN).
Reducing proteinuria, which is associated with the progression of kidney failure, was a primary focus of the study.
The results showed that patients treated with Fabhalta achieved a 38.3% (p<0.0001) reduction in proteinuria at nine months compared to placebo alongside supportive care. Furthermore Fabhalta demonstrated favorable tolerability and safety, consistent with previous findings.
Submission for potential accelerated FDA approval has been accepted and prioritized. The primary endpoint, assessing Fabhalta's ability to slow IgAN progression by measuring the annualized total estimated glomerular filtration rate (eGFR) slope over 24 months, is expected upon study completion in 2025.
David Soergel, M.D., from Novartis, noted the evolving needs of IgAN patients and the diverse therapies in their renal pipeline. Additional real-world studies on IgAN and C3 glomerulopathy (C3G) were presented at WCN, and more data will be forthcoming at future medical gatherings.
Clinical Trial Information
| Study Phase | ClinicalTrial Registration | Clinical Trial Information |
|---|---|---|
It should be noted that the content released in the company statement included forward-looking statements. You can find the full forward statement disclaimer here
Published Study Information
Zhang, H., Rizk, D. V., Perkovic, V., Maes, B., Kashihara, N., Rovin, B., Trimarchi, H., Sprangers, B., Meier, M., Kollins, D., Papachristofi, O., Milojevic, J., Junge, G., Nidamarthy, P. K., Charney, A., & Barratt, J. (2024). Results of a randomized double-blind placebo-controlled Phase 2 study propose iptacopan as an alternative complement pathway inhibitor for IgA nephropathy. Kidney international, 105(1), 189–199. https://doi.org/10.1016/j.kint.2023.09.027
Original Press Release
15 April 2024: New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN)
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This article is compiled from a variety of resources. Every effort has been made to correctly attribute quotes and content. Where possible all information has been independently verified. The Medical Education Network bears no responsibility for any inaccuracies which may occur from the use of third-party sources. If you have any queries regarding this article contact us
Fact-checking Policy
The Medical Education Network makes every effort to review and fact-check the articles used as source material in our summaries and original material. We have strict guidelines in relation to the publications we use as our source data, favouring peer-reviewed research wherever possible. Every effort is made to ensure that the information contained here is an accurate reflection of the original material. Should you find inaccuracies, out of date content or have any additional issues with our articles, please make use of the contact us form to notify us.
