Sparsentan

Sparsentan

Sparsentan

Medication

Sparsentan, sold under the brand name Filspari, is a medication used for the treatment of primary immunoglobulin A nephropathy.[1] Sparsentan is an endothelin and angiotensin II receptor antagonist.[1][2] It is taken by mouth.[1]

Quick Facts Clinical data, Trade names ...

It was approved for medical use in the United States in February 2023.[1][3][4] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[5]

Medical uses

Sparsentan is indicated to reduce proteinuria in people with primary immunoglobulin A nephropathy.[1]

Society and culture

Sparsentan is approved in the US under accelerated approval based on reduction of proteinuria.[1]

In February 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending the granting of a conditional marketing authorization for the medicinal product Filspari, intended for the treatment of adults with primary immunoglobulin A nephropathy (IgAN).[6] The applicant for this medicinal product is Vifor France.[6]

References

  1. [1]
    "Filspari- sparsentan tablet, film coated". DailyMed. 17 February 2023. Retrieved 6 March 2023.
  2. [2]
    Chiu AW, Bredenkamp N (September 2023). "Sparsentan: A First-in-Class Dual Endothelin and Angiotensin II Receptor Antagonist". The Annals of Pharmacotherapy: 10600280231198925. doi:10.1177/10600280231198925. PMID 37706310. S2CID 261743204.
  3. [3]
    "Travere Therapeutics Announces FDA Accelerated Approval of Filspari (sparsentan), the First and Only Non-immunosuppressive Therapy for the Reduction of Proteinuria in IgA Nephropathy" (Press release). Travere Therapeutics. 17 February 2023. Retrieved 17 February 2023 – via GlobeNewswire.
  4. [4]
    Syed YY (April 2023). "Sparsentan: First Approval". Drugs. 83 (6): 563–568. doi:10.1007/s40265-023-01864-x. PMC 10232600. PMID 37022667.
  5. [5]
    New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
  6. [6]
    "Filspari EPAR". European Medicines Agency (EMA). 22 February 2024. Retrieved 24 February 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  • Clinical trial number NCT03762850 for "A Study of the Effect and Safety of Sparsentan in the Treatment of Patients With IgA Nephropathy (PROTECT)" at ClinicalTrials.gov


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