US FDA and EMA accept application for Novartis’ Beovu to treat DME

美国FDA和EMA接受诺华Beovu治疗二甲醚的申请

2021-10-14 22:30:11 PHARMACEUTICAL

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The US Food and Drug Administration has approved biologics license application and the European Medicines Agency has validated the type-II variation application for Novartis’ Beovu to treat patients with diabetic macular edema . Additionally, the application for Beovu was also accepted by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) for treatment of DME. DME is a common microvascular complication in diabetic patients, which will eventually lead to blindness in adults. It is the leading cause of blindness in adults with type 1 and type 2 diabetes. Addressing the burden of frequent treatment schedules and improving fluid resolution are the unmet needs in DME. The company stated that the regulatory applications are based on the year one data obtained from the Phase III KESTREL and KITE studies which compared the safety and efficacy of Beovu six mg with aflibercept two mg in DME patients. In the trial, Beovu met the primary endpoint of non-inferiority in change in best corrected visual acuity (BCVA) from baseline compared to aflibercept. It has also showed potential for fluid resolution in more DME patients with less injections and favourable benefit-risk profile in these studies. Novartis claimed that the two-year KESTREL and KITE studies are the first pivotal trials to evaluate an anti- vascular endothelial growth factor (VEGF) treatment on six-week dosing intervals. Novartis Ophthalmology global development unit head and senior vice president Jill Hopkins said: “People living with diabetes often need to manage multiple comorbidities related to diabetes and there is a significant need to provide better disease management. “If approved, Beovu has the potential to provide better fluid resolution and fewer injections during the loading phase and throughout maintenance treatment.” The company expects the regulatory decisions in the US and Europe for Beovu to treat DME to come in mid of 2022. If approved, DME would be the second indication for Beovu after its approval by FDA and European Commission to treat wet age-related macular degeneration in October 2019 and February 2020, respectively.
美国食品药品监督管理局已经批准了生物制品许可申请,欧洲药品管理局已经验证了诺华公司Beovu治疗糖尿病黄斑水肿患者的II型变异申请。 此外,Beovu的申请也被日本药品和医疗器械机构(PMDA)接受,用于治疗DME。 DME是糖尿病患者常见的微血管并发症,最终会导致成人失明。 它是1型和2型糖尿病成人失明的主要原因。 解决频繁处理时间表的负担和提高流体分辨率是DME尚未满足的需求。 该公司表示,监管申请是基于从第三阶段KESTREL和KITE研究中获得的第一年数据,该研究比较了Beovu 6毫克和aflibercept 2毫克在DME患者中的安全性和有效性。 在试验中,Beovu与AFLibercept相比,符合基线最佳矫正视力(BCVA)变化不劣的主要终点。 在这些研究中,它还显示了在更多的DME患者中使用更少的注射和良好的收益-风险描述的液体分解的潜力。 诺华声称,为期两年的KESTREL和KITE研究是首次评估抗血管内皮生长因子(VEGF)治疗六周剂量间隔的关键试验。 诺华眼科全球发展部门负责人兼高级副总裁吉尔·霍普金斯说:“糖尿病患者经常需要管理与糖尿病相关的多种共病,迫切需要提供更好的疾病管理。 “如果获得批准,Beovu有潜力在装载阶段和整个维护治疗期间提供更好的流体分辨率和更少的注射.” 该公司预计美国和欧洲对Beovu处理二甲醚的监管决定将于2022年年中做出。 如果获得批准,DME将是继美国食品和药物管理局(FDA)和欧盟委员会(European Commission)分别于2019年10月和2020年2月批准治疗湿性年龄相关性黄斑变性后,Beovu的第二个适应症。

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