STOCKHOLM, July 26, 2024 /PRNewswire/ -- Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ('Calliditas') today announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy (IgAN)..

斯德哥尔摩，2024年7月26日/PRNewswire/--Calliditas Therapeutics AB（纳斯达克：CALT，纳斯达克-斯德哥尔摩：CALTX）（“Calliditas”）今天宣布，欧盟委员会已批准Kinpeygo的全面上市许可，用于治疗成人原发性免疫球蛋白a肾病（IgAN）。。

The European Commission has granted a full marketing authorization of Kinpeygo®. The granting of the full approval results in a significantly broader label for patients with primary IgAN, moving from a urine protein excretion (UPCR) limitation of > 1.5g/g to encompassing the entire study population, defined as UPCR of ≥ 0.8g/g, or proteinuria of ≥1.0 g/g over 24 hours.

欧盟委员会已授予Kinpeygo®全面上市授权。完全批准的授予为原发性IgAN患者提供了更广泛的标签，从尿蛋白排泄（UPCR）限制>1.5g/g转变为涵盖整个研究人群，定义为24小时内UPCR≥0.8g/g或蛋白尿≥1.0 g/g。

This expanded label is based on full two-year data set from the Phase 3 NefIgArd clinical trial, published in leading medical journal The Lancet (1)..

这个扩展的标签是基于NefIgArd临床试验第三阶段两年的完整数据集，该试验发表在领先的医学杂志《柳叶刀》（1）上。。

'This is an important event for patients suffering from IgAN in Europe as Kinpeygo represents the first ever fully approved medication for this rare kidney disease.  The long-term confirmatory trial met its eGFR endpoint with high statistical significance and we are delighted that the European Commission has granted a full approval for the broader population' said Renee Aguiar-Lucander, CEO..

“这对欧洲患有IgAN的患者来说是一个重要事件，因为Kinpeygo代表了有史以来第一种完全批准用于治疗这种罕见肾脏疾病的药物。首席执行官蕾妮·阿吉亚·卢坎德（ReneeAguiarLucander）说，这项长期验证性试验达到了eGFR终点，具有很高的统计学意义，我们很高兴欧盟委员会已经批准了更广泛的人群。。

Kinpeygo is marketed in in the EU and UK exclusively by Calliditas' commercial partner, STADA Arzneimittel AG.

Kinpeygo仅由Calliditas的商业合作伙伴STADA Arzneimittel AG在欧盟和英国销售。

The full marketing authorization for Kinpeygo covers the European Union (EU) member states as well as Iceland, Norway and Liechtenstein. Also, Kinpeygo's status as an orphan drug for a rare disease, subject to 10-year market exclusivity running until 2032, was confirmed by the Commission.

Kinpeygo的全面上市授权涵盖欧盟（EU）成员国以及冰岛、挪威和列支敦士登。此外，该委员会还确认了金佩果作为一种罕见疾病的孤儿药的地位，该药将在2032年之前拥有10年的市场独家经营权。

This approval triggers a milestone payment of ten million EUR to Calliditas, which will be recognized as revenue in the third quarter.

这一批准触发了向Calliditas支付1000万欧元的里程碑式付款，这将在第三季度确认为收入。

Efficacy and safety of a targeted-release formulation of budesonide in patients with primary IgA nephropathy (NefIgArd): 2-year results from a randomized phase 3 trial - The Lancet

布地奈德靶向释放制剂对原发性IgA肾病（NefIgArd）患者的疗效和安全性：一项随机3期试验的2年结果-柳叶刀

CONTACT:

联系人：

For further information, please contact:

欲了解更多信息，请联系：

Åsa Hillsten, Head of IR & Sustainability, Calliditas

Ása Hillsten，Calliditas IR和可持续发展负责人

Tel.: +46 76 403 35 43, Email: asa.hillsten@calliditas.com

电话：+46 76 403 35 43，电子邮件：asa.hillsten@calliditas.com

The information was sent for publication, through the agency of the contact person set out above, on July 26, 2024 at 5:00 p.m. CET.

该信息于2024年7月26日下午5:00通过上述联系人的代理发送发布。

This information was brought to you by Cision http://news.cision.com

此信息由Cision提供给您http://news.cision.com

https://news.cision.com/calliditas-therapeutics/r/calliditas-partner-stada-receives-european-commission-decision-for-full-approval-of-kinpeygo--for-th,c4019061

https://news.cision.com/calliditas-therapeutics/r/calliditas-partner-stada-receives-european-commission-decision-for-full-approval-of-kinpeygo--for-th，c4019061

The following files are available for download:

以下文件可供下载：

https://mb.cision.com/Main/16574/4019061/2927743.pdf

https://mb.cision.com/Main/16574/4019061/2927743.pdf

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