Novartis' Wet AMD Drug Wins FDA Approval

FDA批准诺华的湿性AMD药物用于治疗相关性黄斑变性病

2019-10-09 09:00:42 BioSpace

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The U.S. Food and Drug Administration (FDA) approved Novartis’ Beovu (brolucizumab-dbll) for the treatment of wet age-related macular degeneration (AMD), after it stood up to Regeneron’s Eylea (aflibercept) during clinical trials. The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Novartis' drug demonstrated non-inferiority versus Eylea in mean change in best-corrected visual acuity (BCVA) at 48 weeks. In both clinical trials, approximately 30% of patients gained at least 15 letters at that time. The approval from the FDA marks the first approved anti-VEGF that offers both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy, Novartis said this morning. During clinical testing, Beovu hit a number of endpoints, including vision gains that were non-inferior to Eylea at one year, with longer treatment intervals in a majority of patients, the Swiss pharma giant said. Beovu also demonstrated greater reductions in central subfield thickness, which is a key indicator of fluid in the retina as early as 16 weeks after induction. At one year, the reduction was greater than Eylea, Novartis added. In the two Phase III clinical trials that served as the basis for the FDA’s approval, more than half of patients taking Beovu were able to maintain a dosing regimen every three months. In the HAWK trial, 56% of patients stuck to the treatment schedule and in the Phase III HARRIER trial, 51% did so. Less frequent injections are seen as preferable for patients as many wet age-related macular degeneration patients tend to quit frequent treatments, Novartis noted. Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision. Fluid that leaks out of these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula. Beovu is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs, the company said. By inhibiting VEGF, Beovu suppresses the growth of abnormal blood vessels and the potential for fluid leakage into the retina, Novartis added. Wet AMD distorts central vision and ultimately causes blindness. It is estimated that about 1.75 million people in the United States will be living with wet AMD and about 20 million people around the world. Marie-France Tschudin, president of Novartis Pharmaceuticals, pointed to the success Novartis has had in developing a drug that can be administered once every three months. She said competing wet AMD products are not as effective at that dosing interval. “Beovu is the first to offer less frequent dosing in the first year of therapy while maintaining its effectiveness. This gives more time for wet AMD patients to focus on what's important in their lives,” Tschudin said in a statement. Beovu exhibited an overall safety profile comparable to Eylea, Novartis said. Beovu is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or with known hypersensitivity to brolucizumab or any of the inactive substances in the medication.
美国食品药品监督管理局(Food and Drug Administration)( FDA )批准诺华公司( Novartis ’ Beovu )用于治疗湿性年龄相关性黄斑变性( AMD ),此前该公司在临床试验中与再生元(Regeneron)的 Eylea ( aflibercept )对抗。 Beovu 的批准是基于三期 HAWK 和 HARRIER 临床试验的结果,在这两项临床试验中,诺华(Novartis)公司的药物在48周的最佳矫正视力( BCVA )平均变化中表现出非劣效性。在这两个临床试验中,大约30%的患者当时至少获得了15个字母。 诺华公司今天上午表示, FDA 的批准标志着首个获得批准的抗 VEGF 药物,它既能提供更高的液体分辨率,也能在3个月的给药间隔内维持符合条件的湿性 AMD 患者的服用。瑞士制药巨头 Beovu 说,在临床试验中,贝索夫达到了许多终点,包括一年内视力改善不低于 Eyla ,大多数患者的治疗间隔时间更长。Beovu 也表现出更大的中心亚场厚度的减少,这是一个关键的指标流体在视网膜诱导后16周。诺华(Novartis)补充说,在一年的时间里,这一降幅大于埃莱雅。 在作为 FDA 批准的基础的两个 III 期临床试验中,一半以上服用贝伐的患者能够每三个月维持一次给药养生法。在 HAWK 试验中,56%的患者坚持治疗计划,在 III 期 HARRIER 试验中,51%的患者坚持治疗计划。诺华(Novartis)指出,对患者来说,注射次数较少被认为是更好的选择,因为许多湿性年龄相关性黄斑变性患者往往放弃频繁的治疗。 湿性 AMD 是一种慢性、退行性眼病,由过量的 VEGF 引起。 VEGF 是一种蛋白质,促进黄斑下异常血管的生长,黄斑下是视网膜的区域,负责敏锐的中心视力。从这些异常血管流出的液体破坏了正常的视网膜结构,并最终损害了黄斑。该公司表示, Beovu 的设计是提供最高浓度的药物,提供比其他抗 VEGF 更有效的结合剂。诺华(Novartis)公司补充说,通过抑制 VEGF , Beovu 抑制了异常血管的生长,并抑制了液漏入视网膜的可能性。湿性 AMD 扭曲了中心视力,最终导致失明.据估计,美国约有175万人将生活在湿性 AMD 和世界各地约2000万人。 诺华制药( Novartis Pharmaceuticals )总裁玛丽-法兰西•茨楚丁( Marie-France Tschudin )指出,诺华(Novartis)在开发一种每三个月一次的药物方面取得了成功。她说,竞争的湿性 AMD 产品在那个剂量间隔没有那么有效。 “ Beovu 是第一个在治疗的第一年提供较少频繁剂量同时保持其有效性的药物。这为湿性 AMD 患者提供了更多的时间来关注他们生活中重要的事情,” Tschudin 在一份声明中说。 诺华(Novartis)表示, Beovu 的整体安全状况与 Eyla 相当。Beovu 被禁止用于眼或眼周感染、主动眼内炎症或已知对溴露珠单抗或药物中的任何非活性物质过敏症的患者。

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