Ligand Partner Travere Therapeutics Receives Full FDA Approval for FILSPARI® (sparsentan), the Only Non-Immunosuppressive Treatment that Significantly Slows Kidney Function Decline in IgA Nephropathy
Ligand Pharmaceuticals (Nasdaq: LGND) announced that its partner Travere Therapeutics received full FDA approval for FILSPARI® (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) at risk of progression. This approval is based on positive long-term results from the PROTECT Study, showing FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.
Key points:
- FILSPARI is the only non-immunosuppressive treatment for IgAN
- Ligand is entitled to a 9% royalty on worldwide net sales of FILSPARI
- FILSPARI demonstrated superior long-term kidney function preservation compared to irbesartan
- The FDA-approved label includes two-year efficacy data
Ligand's CEO, Todd Davis, expressed optimism about FILSPARI's potential as a significant revenue driver for the company in the coming years.
Ligand Pharmaceuticals (Nasdaq: LGND) ha annunciato che il suo partner Travere Therapeutics ha ricevuto l'approvazione completa della FDA per FILSPARI® (sparsentan) per rallentare il declino della funzionalità renale negli adulti con nefropatia primitiva da IgA (IgAN) a rischio di progressione. Questa approvazione si basa su risultati positivi a lungo termine dello studio PROTECT, che mostrano come FILSPARI abbia significativamente rallentato il declino della funzionalità renale nel corso di due anni rispetto all'irbesartan.
Punti chiave:
- FILSPARI è l'unico trattamento non immunosoppressivo per l'IgAN
- Ligand ha diritto a una royalty del 9% sulle vendite nette mondiali di FILSPARI
- FILSPARI ha dimostrato una preservazione della funzionalità renale a lungo termine superiore rispetto all'irbesartan
- L'etichetta approvata dalla FDA include dati di efficacia di due anni
Il CEO di Ligand, Todd Davis, ha espresso ottimismo riguardo al potenziale di FILSPARI come un motore significativo di entrate per l'azienda nei prossimi anni.
Ligand Pharmaceuticals (Nasdaq: LGND) anunció que su socio Travere Therapeutics recibió la aprobación total de la FDA para FILSPARI® (sparsentan) para ralentizar el declive de la función renal en adultos con nefropatía primaria por IgA (IgAN) con riesgo de progresión. Esta aprobación se basa en resultados positivos a largo plazo del estudio PROTECT, que muestran que FILSPARI ralentizó significativamente el declive de la función renal durante dos años en comparación con el irbesartán.
Puntos clave:
- FILSPARI es el único tratamiento no inmunosupresor para IgAN
- Ligand tiene derecho a una regalía del 9% sobre las ventas netas mundiales de FILSPARI
- FILSPARI demostró una preservación superior de la función renal a largo plazo en comparación con el irbesartán
- La etiqueta aprobada por la FDA incluye datos de eficacia de dos años
El CEO de Ligand, Todd Davis, expresó optimismo sobre el potencial de FILSPARI como un importante impulsor de ingresos para la compañía en los próximos años.
리간드 제약(Ligand Pharmaceuticals, Nasdaq: LGND)는 파트너인 트래버 테라퓨틱스(Travere Therapeutics)가 진행성 위험이 있는 성인의 1차 IgA 신병증(IgAN)에서 신장 기능 저하를 늦추기 위해 FILSPARI® (sparsentan)에 대해 FDA의 완전 승인을 받았다고 발표했습니다. 이번 승인은 PROTECT 연구의 긍정적인 장기 결과를 기반으로 하며, FILSPARI가 irbesartan에 비해 2년 동안 신장 기능 저하를 유의미하게 늦췄음을 보여줍니다.
주요 사항:
- FILSPARI는 IgAN에 대한 유일한 비면역억제 치료제입니다.
- 리간드는 FILSPARI의 전 세계 순매출에 대해 9%의 로열티를 받을 권리가 있습니다.
- FILSPARI는 irbesartan에 비해 장기적인 신장 기능 보존에서 우수성을 입증했습니다.
- FDA 승인 라벨에는 2년의 효능 데이터가 포함되어 있습니다.
리간드의 CEO인 토드 데이비스(Todd Davis)는 FILSPARI가 향후 몇 년 동안 회사의 중요한 수익 원천이 될 잠재성에 대한 낙관적인 의견을 표명했습니다.
Ligand Pharmaceuticals (Nasdaq: LGND) a annoncé que son partenaire Travere Therapeutics a reçu l'approbation complète de la FDA pour FILSPARI® (sparsentan) afin de ralentir le déclin de la fonction rénale chez les adultes atteints de néphropathie primaire à IgA (IgAN) à risque de progression. Cette approbation est basée sur des résultats positifs à long terme de l'étude PROTECT, montrant que FILSPARI a significativement ralenti le déclin de la fonction rénale sur deux ans par rapport à l'irbésartan.
Points clés :
- FILSPARI est le seul traitement non immunosuppresseur pour l'IgAN
- Ligand a droit à une redevance de 9% sur les ventes nettes mondiales de FILSPARI
- FILSPARI a démontré une préservation supérieure de la fonction rénale à long terme par rapport à l'irbésartan
- L'étiquette approuvée par la FDA inclut des données d'efficacité sur deux ans
Le PDG de Ligand, Todd Davis, a exprimé son optimisme concernant le potentiel de FILSPARI comme moteur de revenus significatif pour l'entreprise dans les années à venir.
Ligand Pharmaceuticals (Nasdaq: LGND) gab bekannt, dass ihr Partner Travere Therapeutics die vollständige FDA-Zulassung für FILSPARI® (sparsentan) erhalten hat, um den Rückgang der Nierenfunktion bei Erwachsenen mit primärer IgA-Nephropathie (IgAN) mit Risiko für eine Progression zu verlangsamen. Diese Zulassung basiert auf positiven Langzeitresultaten der PROTECT-Studie, die zeigen, dass FILSPARI die Nierenfunktionsverschlechterung über zwei Jahre im Vergleich zu Irbesartan signifikant verlangsamte.
Wichtige Punkte:
- FILSPARI ist die einzige nicht-immunosuppressive Behandlung für IgAN
- Ligand hat Anspruch auf eine 9% Lizenzgebühr auf den weltweiten Nettoumsatz von FILSPARI
- FILSPARI zeigte eine überlegene langfristige Erhaltung der Nierenfunktion im Vergleich zu Irbesartan
- Das von der FDA genehmigte Etikett enthält Daten zur Wirksamkeit über zwei Jahre
Der CEO von Ligand, Todd Davis, äußerte Optimismus über das Potenzial von FILSPARI als wichtigen Umsatztreiber für das Unternehmen in den kommenden Jahren.
- Full FDA approval received for FILSPARI to treat IgA nephropathy
- FILSPARI demonstrated superior long-term kidney function preservation in clinical trials
- Ligand entitled to 9% royalty on worldwide net sales of FILSPARI
- FILSPARI is the only non-immunosuppressive treatment for IgAN
- Potential for FILSPARI to become foundational care in IgAN treatment
- Positive long-term confirmatory results from the PROTECT Study
- None.
Insights
The FDA's full approval of FILSPARI® for IgA nephropathy (IgAN) represents a significant advancement in kidney disease treatment. As the first non-immunosuppressive therapy to slow kidney function decline in IgAN patients, it addresses a critical unmet need. The PROTECT Study results demonstrate FILSPARI's superiority over irbesartan in preserving kidney function, with a 1.2 mL/min/1.73 m2/year treatment effect (p=0.0168) in eGFR slope.
The dual-action mechanism targeting both endothelin-1 and angiotensin II pathways is innovative, potentially offering a more comprehensive approach to managing IgAN progression. The durable proteinuria reduction and 3.8 mL/min/1.73 m2 difference in mean eGFR change at Week 110 further support FILSPARI's long-term efficacy. This approval could reshape treatment paradigms for IgAN, potentially positioning FILSPARI as a first-line therapy for patients at risk of progression.
The full FDA approval of FILSPARI® is a major catalyst for Ligand Pharmaceuticals. With a
Importantly, as a non-immunosuppressive, once-daily oral medication, FILSPARI has competitive advantages that could lead to substantial market penetration. The potential for FILSPARI to become foundational care in IgAN suggests a long-term, stable revenue source for Ligand. Investors should monitor Travere's commercialization efforts and early sales figures to gauge the drug's market reception and potential impact on Ligand's financials. The possibility of a REMS modification could further improve the drug's market position.
FDA approves expanded indication making FILSPARI available to patients with IgA nephropathy (IgAN) at risk of progression; updated label includes data showing long-term durable benefit on proteinuria and kidney function preservation that accrued over two years
Conversion to full approval based on results from the PROTECT Study, where FILSPARI delivered superior long-term kidney function preservation compared to the active comparator irbesartan in the only Phase 3 head-to-head trial conducted in IgAN
As an oral, non-immunosuppressive and dual acting, once-daily medicine with superior long-term results vs. irbesartan, FILSPARI has the potential to become foundational care in IgAN
Ligand is entitled to a
FILSPARI was granted accelerated approval in February 2023 based on the surrogate marker of proteinuria. Full approval is based on positive long-term confirmatory results from the PROTECT Study demonstrating that FILSPARI significantly slowed kidney function decline over two years compared to irbesartan.
“This announcement is a momentous milestone for Travere and a positive development for people living with this rare kidney disease,” said Todd Davis, CEO of Ligand. “We are encouraged by Travere’s progress to drive adoption of FILSPARI in the
FILSPARI is the only oral, once-daily, non-immunosuppressive medication that directly targets glomerular injury in the kidney by blocking two critical pathways of IgAN disease progression (endothelin-1 and angiotensin II).
The two-year efficacy data contained in the FDA-approved label is a modified intention to treat (ITT) analysis, and as preferred by the FDA, evaluates data from all patients regardless of treatment discontinuation. In the final analysis of the 404 randomized patients, FILSPARI significantly reduced the rate of decline in kidney function from baseline to Week 110 compared to irbesartan. In the ITT analysis included in the label, the mean eGFR slope from baseline to Week 110 was -3.0 mL/min/1.73 m2/year for FILSPARI and -4.2 mL/min/1.73 m2/year for irbesartan, corresponding to a statistically significant treatment effect of 1.2 mL/ min/1.73 m2/year (p=0.0168). The positive treatment effects on proteinuria compared to the active control irbesartan that were observed at Week 36 were durable out to the two-year measurement period. Additional results from the PROTECT Study demonstrated the benefit of FILSPARI on absolute eGFR accrued over time and by Week 110 resulted in a 3.8 mL/min/1.73 m2 difference in the mean change from baseline between FILSPARI and irbesartan.
Results from the PROTECT Study showed that FILSPARI was well tolerated with a clearly defined safety profile that has been consistent across all clinical trials conducted to date. Following engagement with the FDA, the Company expects to submit an sNDA for a potential modification to the liver-monitoring REMS.
About IgA Nephropathy
IgA nephropathy (IgAN), also called Berger's disease, is a rare progressive kidney disease characterized by the buildup of immunoglobulin A (IgA), a protein that helps the body fight infections, in the kidneys. The deposits of IgA cause a breakdown of the normal filtering mechanisms in the kidney, leading to blood in the urine (hematuria), protein in the urine (proteinuria) and a progressive loss of kidney function. Other symptoms of IgAN may include swelling (edema) and high blood pressure.
IgAN is the most common type of primary glomerulonephritis worldwide and a leading cause of kidney failure due to glomerular disease. IgAN is estimated to affect up to 150,000 people in the
About the PROTECT Study
The PROTECT Study is one of the largest interventional studies to date in IgA nephropathy (IgAN) and the only Phase 3 head-to-head trial in this rare kidney disease. It is a global, randomized, multicenter, double-blind, parallel-arm, active-controlled clinical trial evaluating the safety and efficacy of 400 mg of FILSPARI (sparsentan), compared to 300 mg of irbesartan, in 404 patients ages 18 years and up with IgAN and persistent proteinuria despite receiving at least
The primary efficacy endpoint for the interim analysis was the change from baseline in urine protein/creatinine ratio at Week 36. The key secondary efficacy endpoint for the final analysis was the rate of change in eGFR over a 110-week period following initiation of randomized therapy.
The trial met the pre-specified primary endpoint which showed that after 36 weeks patients receiving FILSPARI achieved a mean reduction in proteinuria from baseline of
The two-year efficacy data contained in the FDA-approved label is a modified intention to treat (ITT) analysis, and as preferred by the FDA, evaluates data from all patients regardless of treatment discontinuation. In the final analysis of 404 randomized patients, FILSPARI reduced the rate of decline in kidney function from baseline to Week 110 compared to irbesartan. The mean eGFR slope from baseline to Week 110 was -3.0 mL/min/1.73 m2/year for FILSPARI and -4.2 mL/min/1.73 m2/year for irbesartan, corresponding to a statistically significant treatment effect of 1.2 mL/ min/1.73 m2/year (p=0.0168).
Additional results from the PROTECT Study demonstrated the benefit of FILSPARI on absolute eGFR accrued over time and by Week 110 resulted in a 3.8 mL/min/1.73 m2 difference in the mean change from baseline between FILSPARI and irbesartan.
Patients who completed the PROTECT double-blind portion of the study on treatment were eligible to participate in the open-label extension of the trial.
About Ligand Pharmaceuticals
Ligand is a biopharmaceutical company enabling scientific advancement through supporting the clinical development of high-value medicines. Ligand does this by providing financing, licensing our technologies or both. Its business model seeks to generate value for stockholders by creating a diversified portfolio of biopharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Ligand’s goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable and diversified manner. Its business model focuses on funding programs in mid- to late-stage drug development in return for economic rights, purchasing royalty rights in development stage or commercial biopharmaceutical products and licensing its technology to help partners discover and develop medicines. Ligand partners with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) in order to generate its revenue. Ligand’s Captisol® platform technology is a chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Ligand has established multiple alliances, licenses and other business relationships with the world’s leading biopharmaceutical companies including Amgen, Merck, Pfizer, Jazz, Takeda, Gilead Sciences, and Baxter International. For more information, please visit at www.ligand.com. Follow Ligand on X @Ligand_LGND.
We use our investor relations website and X as a means of disclosing material non-public information and for complying with our disclosure obligations under Regulation FD. Investors should monitor our website and our X account, in addition to following our press releases, SEC filings, public conference calls and webcasts.
Forward-Looking Statements
This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: the timing of the commercial launch of FILSPARI by Travere and the potential contribution it is expected to bring to Ligand; the timing and amount of milestone payments in connection with FILSPARI that Ligand expects; and the potential royalties to be paid on sales of FILSPARI by Travere. Actual events or results may differ from Ligand’s or its partner’s expectations due to risks and uncertainties inherent in Ligand’s and its partner’s business, including, without limitation: Travere may not be able to successfully commercialize FILSPARI which will depend on a number of factors including coverage and reimbursement levels from governmental authorities and health insurers as well as market acceptance by healthcare providers; the market size for FILSPARI may be smaller than estimated; Ligand is dependent on Travere for the commercialization of FILSPARI; and other risks described in Ligand’s prior press releases and filings with the Securities and Exchange Commission available at www.sec.gov. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand’s stock price. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
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Source: Ligand Pharmaceuticals Incorporated
FAQ
What is the FDA-approved indication for FILSPARI (sparsentan)?
How does FILSPARI compare to irbesartan in treating IgA nephropathy?
What royalty is Ligand Pharmaceuticals (LGND) entitled to for FILSPARI sales?
How does FILSPARI work in treating IgA nephropathy?
What were the key findings from the PROTECT Study for FILSPARI?
