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Home » Keywords » Filspari

Items Tagged with 'Filspari'

ARTICLES

IgAN again: Novartis gets second approval in rare kidney disease

April 3, 2025
By Lee Landenberger
The U.S. FDA’s accelerated approval of Vanrafia (atrasentan) from Novartis AG for primary immunoglobulin A nephropathy (IgAN) is the company’s second approval for the indication in the past year and a half. The nod also came without a required safety program through a black box warning.
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Filspari

Travere’s Filspari safari bags full FDA nod in IgAN; REMS next

Sep. 6, 2024
By Randy Osborne
With full approval from the U.S. FDA in hand for Travere Therapeutics Inc.’s Filspari (sparsentan) to slow kidney function decline in adults with primary IgA nephropathy (IgAN) who are at risk of disease progression, eyes turned to future prospects as well as how a revised risk evaluation and mitigation strategies (REMS) program might shake out. During a conference call hosted by Travere, Leerink analyst Joseph Schwartz wanted to know what changes might be made, and if the regulator’s decision might “actually be an entire removal” of the REMS.
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EU flag, syringe, capsules

Sparsentan and two bird flu vaccines in EU positive opinion list

Feb. 23, 2024
By Caroline Richards
Seven new therapies, including two influenza vaccines, were recommended for approval by the EMA’s Committee for Medicinal Products for Human Use during its February 2024 meeting. One of these was sparsentan by CSL Vifor Pharma Inc. and Travere Therapeutics Inc. for the treatment of IgA nephropathy (IgAN), for which the committee has awarded conditional marketing authorization.
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Kidney disease illustration

Travere licenses out rare kidney disease drug to Renalys in Asia

Jan. 30, 2024
By Marian (YoonJee) Chu
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
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Kidney disease illustration

Travere licenses out rare kidney disease drug to Renalys in Asia

Jan. 29, 2024
By Marian (YoonJee) Chu
Travere Therapeutics Inc. inked a licensing deal with Tokyo-based Renalys Pharma Inc. to develop sparsentan in 13 Asian countries, becoming the latest news to heat up the immunoglobulin A nephropathy (IgAN) therapy space.
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Kidney, pills, bottle

Filspari trips in IgAN phase III; data good enough to Protect against FDA withdrawal?

Sep. 21, 2023
By Randy Osborne
Travere Therapeutics Inc.’s narrow phase III miss in the study called Protect with the approved endothelin and angiotensin II receptor antagonist Filspari (sparsentan) in IgA nephropathy (IgAN) had Wall Street speculating about the fate of the compound, which is available for the indication by way of accelerated approval in the U.S., having been given the nod in February.
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Approved stamp

Armed with new tools, US FDA picks up pace of accelerated approvals

May 12, 2023
By Mari Serebrov
Despite congressional concerns about accelerated approval, the U.S. FDA’s use of the pathway is not slowing down. If anything, it’s picked up pace since Congress gave the agency stronger authority last year to monitor drugs approved based on a surrogate endpoint and to ensure that confirmatory trials are progressing in a timely way.
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Kidney disease illustration

Travere to deal with FDA after Filspari door number two opens weak in FSGS Duplex trial

May 2, 2023
By Randy Osborne
Saddled with disappointing results from a phase III trial with Filspari (sparsentan) in focal segmental glomerulosclerosis (FSGS), officials of Travere Therapeutics Inc. stressed the differences between that disorder and IgA nephropathy (IgAN) – for which the drug was cleared by the U.S. FDA in February. Two-year IgAN efficacy data are due in the fourth quarter of this year.
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US FDA grants accelerated approval for Travere’s Filspari for rare kidney disorder

Feb. 17, 2023
By Karen Carey
San Diego-based Travere Therapeutics Inc. gained U.S. FDA accelerated approval for its dual endothelin angiotensin receptor antagonist, Filspari (sparsentan), to reduce proteinuria in adults with primary IgA nephropathy, or Berger’s disease.
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