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10 Sep 2024
Admin
News Article

UFA Gives Approval Approval To Travere Therapeutics’ Filspari Sparsentan

The US Food and Drug Administration (FDA) has granted full approval to Travere Therapeutics’ Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN).

Overview

Affecting up to 150,000 people in the US, IgAN occurs when IgA accumulates in the kidneys and damages them. This impairs their filtering function and, as a result, the kidneys start to let substances such as blood and protein leak into the urine.

About Filspari

Filspari, which was approved under the FDA’s accelerated approvals pathway in February 2023 for primary IgAN patients who are at risk of rapid disease progression, is an oral, once-daily non-immunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression.

Drugs Indications Post Approval

The regulator’s latest decision expands the drug’s indication to cover all patients who are at risk of disease progression and was supported by positive long-term confirmatory results from the phase 3 PROTECT study, in which Filspari significantly slowed kidney function decline over two years compared to irbesartan.

The positive treatment effects on proteinuria (protein in the urine) compared irbesartan that were observed at week 36 were durable out to the two-year measurement period, and results showed that Filspari was well tolerated with a “clearly defined” safety profile consistent across all clinical trials conducted to date, Travere said.

Words from the CEO: Travere Therapeutics

The company’s president and chief executive officer, Eric Dube, said: “We know that most people living with IgAN are at risk of disease progression and are seeking a safe, effective and convenient treatment option that can help preserve their kidney function.
Full approval now enables physicians to confidently prescribe Filspari more broadly as a once-daily, oral, non-immunosuppressive treatment that can provide superior preservation of kidney function and replace current standard of care.”

The announcement comes just one month after the FDA granted accelerated approval to Novartis’ Fabhalta (iptacopan) to reduce proteinuria in adults with IgAN at risk of rapid disease progression.

About Fabhalta

Fabhalta is an oral factor B inhibitor of the alternative complement pathway and is already approved in the US to treat adults with the rare blood disorder paroxysmal nocturnal haemoglobinuria.

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