Is sparsentan an FDA-approved drug?

The US Food and Drug Administration has granted full approval to Travere Therapeutics’ sparsentan (Filspari) for slowing kidney function decline in adults with primary IgA nephropathy (IgAN) at risk of disease progression.

Announced on September 5, 2024, the decision is based on 2-year confirmatory results from the phase 3 PROTECT study, the largest head-to-head interventional study to date in IgAN and the only one to be conducted versus an active comparator. The conversion from accelerated to full approval makes sparsentan the second therapeutic to receive full approval for IgAN, following last year’s approval of Calliditas Therapeutics’ budesonide (Tarpeyo) delayed-release capsules.

Drug interactions

Renin-Angiotensin System (RAS) Inhibitors and ERAs: Do not coadminister FILSPARI with ARBs, ERAs, or aliskiren due to increased risks of hypotension, syncope, hyperkalemia, and changes in renal function (including acute renal failure).

Strong and Moderate CYP3A Inhibitors: Avoid concomitant use of FILSPARI with strong CYP3A inhibitors. If a strong CYP3A inhibitor cannot be avoided, interrupt FILSPARI treatment. When resuming treatment with FILSPARI, consider dose titration. Monitor blood pressure, serum potassium, edema, and kidney function regularly when used concomitantly with moderate CYP3A inhibitors. Concomitant use with a strong CYP3A inhibitor increases sparsentan exposure, which may increase the risk of FILSPARI adverse reactions.

Strong CYP3A Inducers: Avoid concomitant use with a strong CYP3A inducer. Concomitant use with a strong CYP3A inducer decreases sparsentan exposure, possibly reducing FILSPARI efficacy.

Antacids and Acid Reducing Agents: Administer FILSPARI 2 hours before or after administration of antacids. Avoid concomitant use of acid-reducing agents (histamine H2 receptor antagonist and PPI proton pump inhibitor) with FILSPARI. Sparsentan exhibits pH-dependent solubility. Antacids or acid-reducing agents may decrease sparsentan exposure, which may reduce FILSPARI efficacy.

Non-steroidal anti-inflammatory Agents (NSAIDs), Including Selective Cyclooxygenase-2 (COX-2) Inhibitors: Monitor for signs of worsening renal function with concomitant use with NSAIDs (including selective COX-2 inhibitors). In patients with volume depletion (including those on diuretic therapy) or with impaired kidney function, concomitant use of NSAIDs (including selective COX-2 inhibitors) with drugs that antagonize the angiotensin II receptor may result in deterioration of kidney function, including possible kidney failure.

CYP2B6, 2C9, and 2C19 Substrates: Monitor for the efficacy of concurrently administered CYP2B6, 2C9, and 2C19 substrates and consider dosage adjustment in accordance with the Prescribing Information. Sparsentan decreases exposure to these substrates, which may reduce efficacy related to these substrates.

P-gp and BCRP Substrates: Avoid concomitant use of sensitive substrates of P-gp and BCRP with FILSPARI. Sparsentan may increase exposure of these transporter substrates, which may increase the risk of adverse reactions related to these substrates.

Agents Increasing Serum Potassium: Monitor serum potassium frequently in patients treated with FILSPARI and other agents that increase serum potassium. Concomitant use of FILSPARI with potassium-sparing diuretics, potassium supplements, potassium-containing salt substitutes, or other drugs that raise serum potassium levels may result in hyperkalemia.

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