‘Rare Kidney Disease Drug’ From Novartis Shows Positive Interim Results

(CTN News) – A new drug being studied to treat a rare kidney disease received positive interim results from Novartis on Monday.

According to Novartis, the treatment, Iptacopan, has achieved significant clinical results over a nine-month period in a study, called APPLAUSE-IgAN, for patients with immunoglobulin A (IgA) nephropathy, or IgAN.

There is a rare autoimmune Kidney Disease known as IgAN that mostly affects young adults and can cause kidney disease failure as a result.

It is expected that the study will continue for a further 15 months. There will be approximately 450 adult patients who are at high risk of progression to renal failure as a result of primary IgAN as part of this project.

As stated by the company, Iptacopan had, in the interim results, “demonstrated superiority to placebo in the reduction of proteinuria (protein in urine) and provided a clinically meaningful reduction in proteinuria that was highly statistically significant”.

According to the Swiss group, it intends to submit the results to the US drug agency, the FDA, by the end of 2024 for an accelerated approval process.

Each year, about 25 out of every million people around the world are diagnosed with IgAN.

According to Novartis, IgAN, a condition in which there is an autoimmune reaction to a variation of IgA, results in the formation of immune complexes that deposit in the Kidney Disease, ultimately causing progressive damage and eventual kidney failure.

There is evidence to suggest that up to 30% of people who have IgAN and who have persistent high levels of proteinuria will suffer kidney failure within the next 10 years as a result of the condition.

In a market commentary, Stefan Schneider, an analyst at Vontobel, said that Iptacopan can be seen as a pipeline contained within a tablet.

As a result of the treatment, he said that paroxysmal nocturnal hemoglobinuria had already shown positive results, a rare Kidney Disease characterized by sudden, often nocturnal outbreaks of red blood cell destruction.

Based on Schneider’s estimate, the peak sales potential of the new drug is estimated to be $2.7 billion – $1,7 billion just to treat IgA nephropathy.

IgA nephropathy is one of the most common forms of glomerulonephritis, an inflammation of the filters of the Kidney Disease, among rare diseases.

As part of its ongoing research, Novartis is developing Iptacopan for several rare diseases, including paroxysmal nocturnal hemoglobinuria, IgA nephropathy, and C3 glomerulopathy.

In a recent announcement, the Food and Drug Administration (FDA) has granted therapeutic breakthrough status to this treatment.

It has been reported that Novartis shares are up 0.35 percent in early trading on Monday, with the overall market adding 0.48 percent to 94.20 Swiss francs ($103).

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