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Aurinia Announces European Commission Approval Of LUPKYNIS For The Treatment Of Lupus Nephritis
Aurinia Announces European Commission Approval Of LUPKYNIS For The Treatment Of Lupus Nephritis
Approval follows the positive opinion granted by European Committee for Medicinal Products for Human Use (CHMP) in July 2022
LUPKYNIS is the first oral medicine approved in both the U.S. and Europe for the treatment of adults living with active lupus nephritis
Approval triggers $30.0 million milestone payment, to be recognized as revenue in the 3rd quarter
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
"Today marks the first approved oral treatment for lupus nephritis in both the European Union and provides adults across Europe living with this potentially life-threatening disease a new treatment option," said Peter Greenleaf, President and Chief Executive Officer, Aurinia. "People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, we're excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes."
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia will receive a $30.0 million EC approval-related milestone payment to be recognized as revenue in the quarter, with receipt of cash to follow within 30 days of invoicing. In addition to the milestone payment, Aurinia is eligible to receive further payments tied to additional regulatory and reimbursement milestones, low double-digit royalties on future net sales, as well as revenues for the supply of product to Otsuka under a cost-plus arrangement.
A decision on marketing authorization for LUPKYNIS in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.
The EC approval of LUPKYNIS is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
Approval follows the positive opinion granted by European Committee for Medicinal Products for Human Use (CHMP) in July 2022
批准之前,欧洲人用药品委员会(CHMP)于2022年7月给予了积极的评价
LUPKYNIS is the first oral medicine approved in both the U.S. and Europe for the treatment of adults living with active lupus nephritis
LUPKYNIS是第一种在美国和欧洲被批准用于治疗成人活动性狼疮性肾炎的口服药物
Approval triggers $30.0 million milestone payment, to be recognized as revenue in the 3rd quarter
批准触发3000万美元的里程碑付款,将在第三季度确认为收入
Aurinia Pharmaceuticals Inc. (NASDAQ:AUPH) (Aurinia or the Company), a biopharmaceutical company committed to delivering therapeutics that change the trajectory of autoimmune disease, announced that the European Commission (EC) has granted marketing authorization of LUPKYNIS (voclosporin) to treat adults with active lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE). The U.S. Food and Drug Administration (FDA) approved LUPKYNIS on January 22, 2021, in combination with a background immunosuppressive therapy regimen to treat adult patients with active LN.
亚洲网加利福尼亚州圣何塞10月23日电致力于提供改变自身免疫性疾病发展轨迹的疗法的生物制药公司奥瑞尼亚制药公司(纳斯达克代码:AUPH)宣布,欧洲委员会(EC)已批准LUPKYNIS(Volosporin)用于治疗成人活动性狼疮性肾炎(LN),这是系统性红斑狼疮(SLE)的一种严重并发症。美国食品和药物管理局(FDA)于2021年1月22日批准LUPKYNIS结合背景免疫抑制疗法治疗活动期LN成人患者。
The centralized marketing authorization is valid in all European Union (EU) member states as well as in Iceland, Liechtenstein, Norway and Northern Ireland.
集中营销授权在所有欧洲联盟(EU)成员国以及冰岛、列支敦士登、挪威和北爱尔兰有效。
"Today marks the first approved oral treatment for lupus nephritis in both the European Union and provides adults across Europe living with this potentially life-threatening disease a new treatment option," said Peter Greenleaf, President and Chief Executive Officer, Aurinia. "People with lupus nephritis and their physicians have long been challenged by the lack of treatments available. In partnership with Otsuka, we're excited to reach patients across Europe with a meaningful therapy that can help enable positive long-term kidney outcomes."
Auinia首席执行官彼得·格林利夫、总裁说:“今天是欧盟和欧盟批准的第一个治疗狼疮性肾炎的口服疗法,并为欧洲各地患有这种潜在威胁生命的疾病的成年人提供了一个新的治疗选择。狼疮性肾炎患者和他们的医生长期以来一直受到缺乏治疗的挑战。与大冢合作,我们很高兴能为欧洲各地的患者提供一种有意义的治疗方法,有助于实现积极的长期肾脏结果。
Aurinia and Otsuka Pharmaceutical Co., Ltd., (Otsuka) entered a collaboration and licensing agreement in December 2020 for the development and commercialization of voclosporin for the treatment of LN in the EU, Japan, the United Kingdom, Russia, Switzerland, Norway, Belarus, Iceland, Liechtenstein, and Ukraine. As part of the agreement, Aurinia will receive a $30.0 million EC approval-related milestone payment to be recognized as revenue in the quarter, with receipt of cash to follow within 30 days of invoicing. In addition to the milestone payment, Aurinia is eligible to receive further payments tied to additional regulatory and reimbursement milestones, low double-digit royalties on future net sales, as well as revenues for the supply of product to Otsuka under a cost-plus arrangement.
奥里尼亚公司和大冢制药有限公司(大冢)于2020年12月达成合作和许可协议,在欧盟、日本、英国、俄罗斯、瑞士、挪威、白俄罗斯、冰岛、列支敦士登和乌克兰开发用于治疗狼疮的沃洛孢菌素并将其商业化。作为协议的一部分,aurinia将收到与欧盟批准相关的3000万美元的里程碑式付款,该付款将在本季度确认为收入,并在开具发票后30天内收到现金。除了里程碑式的付款外,aurinia还有资格获得与额外的监管和补偿里程碑相关的进一步付款,未来净销售额的较低两位数特许权使用费,以及根据成本加成安排向大冢供应产品的收入。
A decision on marketing authorization for LUPKYNIS in Great Britain is expected from the UK Medicines and Healthcare products Regulatory Agency in the coming weeks. In addition, a marketing authorization application (MAA) for LUPKYNIS was submitted to the Swiss Agency for Therapeutic Products (Swissmedic) and is currently under review. Swissmedic previously granted orphan drug status to voclosporin in LN in February 2022.
LUPKYNIS在英国的营销授权预计将在未来几周内由英国药品和保健产品监管机构做出决定。此外,LUPKYNIS的营销授权申请(MAA)已提交给瑞士治疗产品机构(Swissmedic),目前正在审查中。Swissmedic此前于2022年2月在LN批准了Volosporin的孤儿药物地位。
The EC approval of LUPKYNIS is based on the results of the pivotal Phase 3 AURORA 1 study and the recent AURORA 2 continuation study, which demonstrated voclosporin, in combination with mycophenolate mofetil (MMF) and low-dose corticosteroids, led to statistically superior complete renal response rates at 52 weeks compared to MMF and low-dose corticosteroids alone. The safety profile of voclosporin and MMF and low-dose corticosteroids was generally comparable to MMF and low-dose corticosteroids alone.
欧盟委员会对LUPKYNIS的批准是基于关键的3期Aurora 1研究和最近的Aurora 2继续研究的结果,这项研究表明,与MMF和小剂量皮质类固醇联合使用沃洛孢素,在52周时导致与MMF和小剂量皮质类固醇单独使用相比,具有统计上更高的完整肾脏应答率。Voslosporin、MMF和小剂量皮质类固醇的安全性与单独使用MMF和小剂量皮质类固醇大致相当。
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