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特拉维雷、ESL在欧盟获得肾脏疾病治疗的有条件批准
2024-04-24 20:31
- Travere Therapeutics (NASDAQ:TVTX) and CSL Vifor, the U.S. biotech's partner for its kidney disease drug Filspari, announced Wednesday that the European Commission granted conditional marketing authorization for the treatment.
- Accordingly, Filspari, a once-daily oral medication, will be indicated in the EU as well as Iceland, Liechtenstein, and Norway for adults with primary IgA nephropathy, a rare immune-mediated kidney disease.
- The decision comes after an expert panel of the EU drug regulator, the European Medicines Agency, endorsed the treatment in February based on data from the companies’ pivotal Phase 3 PROTECT study, which reached its primary goal.
- CSL Vifor, a unit of Australian pharma CSL (OTCQX:CSLLY) (OTCQX:CMXHF), which has inked a licensing deal with Travere (TVTX) for Filspari’s EU rights, expects to roll out the drug in the region in H2 2024.
More on Travere Therapeutics
- Travere Therapeutics, Inc. (TVTX) Q4 2023 Earnings Call Transcript
- Travere Therapeutics: Restructuring Away From Disaster
- Travere Therapeutics gains as EU backs kidney disease therapy
- Travere Therapeutics Q4 2023 Earnings Preview
- Seeking Alpha’s Quant Rating on Travere Therapeutics
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