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Home » IgAN

Articles Tagged with ''IgAN''

Illustration of kidney with DNA structures
Nephrology

Purespring’s PS-002 designated orphan drug for IgA nephropathy

April 28, 2025
The EMA has granted European orphan drug designation to Purespring Therapeutics Ltd.’s PS-002 for IgA nephropathy (IgAN).
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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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Doctor with illustration of kidneys

Otsuka submits first BLA to FDA for sibeprenlimab in IgAN

April 1, 2025
By Tamra Sami
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
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Doctor with illustration of kidneys

Otsuka submits first BLA to FDA for sibeprenlimab in IgAN

March 31, 2025
By Tamra Sami
Otsuka Pharmaceutical Development & Commercialization Inc. filed its BLA with the U.S. FDA for sibeprenlimab to treat immunoglobulin A nephropathy (IgAN). The company’s first BLA, sibeprenlimab is a monoclonal antibody (MAb) that selectively inhibits the activity of APRIL (A PRoliferation-Inducing Ligand) in adults with IgAN.
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3D illustration of kidney cross section

Otsuka says IgAN, too, with phase III sibeprenlimab data

Oct. 29, 2024
By Marian (YoonJee) Chu
Visterra Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., reported positive top-line data from the ongoing Visionary phase III study of sibeprenlimab, an anti-APRIL monoclonal antibody for immunoglobulin A nephropathy (IgAN).
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3D illustration of kidney cross section

Otsuka says IgAN, too, with phase III sibeprenlimab data

Oct. 25, 2024
By Marian (YoonJee) Chu
Visterra Inc., a subsidiary of Otsuka Pharmaceutical Co. Ltd., reported positive top-line data from the ongoing Visionary phase III study of sibeprenlimab, an anti-APRIL monoclonal antibody for immunoglobulin A nephropathy (IgAN).
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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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Yes, IGaN: Novartis’ proteinuria therapy receives FDA approval

Aug. 8, 2024
By Lee Landenberger
The U.S. FDA has granted accelerated approval to Novartis AG’s Fabhalta (iptacopan) for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. The approval strengthens the company’s renal disease presence as it puts two other IgAN treatments through clinical trials.
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Illustration of kidney with DNA structures

Vertex buying Alpine for $4.9B for phase III-ready IgAN asset

April 11, 2024
By Tamra Sami
Vertex Pharmaceuticals Inc. is acquiring Alpine Immune Sciences Inc. for $4.9 billion in cash to gain Alpine’s lead product, phase III-ready povetacicept, which demonstrates best-in-class potential in patients with immunoglobulin A nephropathy (IgAN). Povetacicept (ALPN-303), or “pove,” holds potential “as a pipeline in a product in a number of other serious renal diseases and cytopenias,” Vertex CEO Reshma Kewalramani said during an April 10 conference call, noting that the deal was “just the right fit with just the right assets at just the right phase of development where Vertex can add value.”
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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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