Travere Therapeutics’ Kidney Disorder Drug Approved by US FDA

HEALTHCARE

A novel treatment for a rare kidney disease developed by Travere Therapeutics has received US FDA approval.

The US FDA granted the drug, which is called sparsentan, an expedited approval for the treatment of primary immunoglobulin A nephropathy (IgAN), which is prone to rapid disease progression. The first non-immunosuppressive treatment for IgAN to be approved is the drug, which is now sold under the brand name Filspari.

Travere CEO Eric Dube explained that Filspari works by blocking both endothelin and angiotensin receptors.

This distinguishes Filspari from angiotensin-targeting ACE inhibitors and ARBs, which are commonly prescribed medications primarily for the treatment of high blood pressure but have been repurposed for IgAN due to their capacity to lower kidney blood pressure. Additionally, the mechanism distinguishes Filspari from endothelin receptor antagonists like Johnson & Johnson’s Tracleer for pulmonary arterial hypertension.

Additionally, there is Calliditas Therapeutics’ Tarpeyo, a formulation of the well-known corticosteroid budesonide that became the first drug that the FDA specifically approved for IgAN toward the end of 2021. However, doctors and patients typically do not want to use steroids due to side effects, according to Dube.

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Approximately 90% of IgAN patients are currently taking an ACE inhibitor or an ARB. According to Eric Dube, however, blocking angiotensin by itself is insufficient for patients whose disease is more severe and is progressing.

In addition to Filspari, Travere already has relationships with approximately 2,000 nephrologists and sells the kidney stone treatment Thiola. Dube suggested that the company be able to quickly carry out its launch strategy for Filspari because the business had expanded its commercial infrastructure even more the year before.