CSL Vifor and Travere Therapeutics have received full marketing authorisation from the European Commission for FILSPARI® to treat adults with primary IgA nephropathy (IgAN).

CSL Vifor和Travere Therapeutics已获得欧盟委员会的全面上市许可，FILSPARI®将用于治疗患有原发性IgA肾病（IgAN）的成人患者。

Nephropathy is a general term used to describe damage or disease affecting the kidneys. It can result from various causes, including diabetes, high blood pressure, or autoimmune conditions. One specific form, IgA nephropathy (IgAN), involves the build-up of the IgA antibody in the kidneys, leading to inflammation and impaired kidney function.

肾病是一个用来描述影响肾脏的损伤或疾病的总称。它可能由多种原因引起，包括糖尿病、高血压或自身免疫性疾病。其中一种特定形式是IgA肾病（IgAN），涉及IgA抗体在肾脏中的积累，导致炎症和肾功能受损。

Over time, this can cause a gradual decline in kidney performance and may progress to chronic kidney disease if not effectively managed..

随着时间的推移，这可能会导致肾脏功能逐渐下降，如果不能有效管理，可能会发展为慢性肾脏病。

This decision converts the previous conditional marketing approval into a standard authorisation across all European Union member states, as well as Iceland, Liechtenstein and Norway. The approval covers patients with urine protein excretion of 1.0 g/day or higher, or a urine protein-to-creatinine ratio of at least 0.75 g/g..

该决定将以前的有条件营销批准转换为涵盖所有欧盟成员国以及冰岛、列支敦士登和挪威的标准授权。 批准涵盖尿蛋白排泄量为每天 1.0 克或更高，或尿蛋白与肌酐比率至少为 0.75 克/克的患者。

The standard authorisation was granted without any changes to the previously approved indication. This follows the February 2025 recommendation from the Committee for Medicinal Products for Human Use (CHMP) to transition from a conditional to a standard approval.

标准授权在之前批准的适应症没有任何变更的情况下获得通过。这是遵循了人用药品委员会 (CHMP) 在2025年2月提出的建议，即从有条件批准过渡到标准批准。

The decision is based on a robust clinical evidence package, including data from the pivotal Phase III PROTECT study. Results from this study showed that FILSPARI significantly slowed the decline of kidney function over a two-year period when compared to irbesartan.

该决定基于强大的临床证据包，包括关键的 III 期 PROTECT 研究的数据。这项研究的结果表明，与厄贝沙坦相比，FILSPARI 在两年内显著减缓了肾功能的下降。

FILSPARI remains the only Dual Endothelin Angiotensin Receptor Antagonist (DEARA) approved in Europe for the treatment of IgAN. It offers a non-immunosuppressive therapy option and is already available in Germany, Austria and Switzerland under the previous conditional approval granted in April 2024..

FILSPARI仍然是欧洲唯一获批用于治疗IgAN的双重内皮素血管紧张素受体拮抗剂（DEARA）。它提供了一种非免疫抑制的治疗选择，并且自2024年4月获得之前的有条件批准后，已经在德国、奥地利和瑞士上市。

The companies aim to continue working with healthcare providers, regulatory authorities, and patient organisations to expand access to this treatment and improve outcomes for those affected by IgA nephropathy across Europe.

这些公司旨在继续与医疗保健提供者、监管机构和患者组织合作，以扩大这种治疗的可及性，并改善整个欧洲受 IgA 肾病影响的患者的治疗效果。