Polihexanide

▎药明康德内容团队编辑 SIFI公司今日宣布，欧盟委员会已批准Akantior（polihexanide）上市，用于治疗12岁以上棘阿米巴性角膜炎（AK）青少年和成人患者。新闻稿指出，Akantior是欧洲首个获批用于治疗AK的疗法。 AK是一种极为罕见、严重、进行性并威胁视力的角膜感染。它可能导致视力低下、潜在的失明甚至失去眼球，通常需要单次或多次角膜移植。它影响所有年龄段的人群，其中大多数是年轻或中年软性隐形眼镜佩戴者。患者报告难以忍受的疼痛和极度的畏光，症状缓解之前很少能正常工作或生活。 Akantior（0.08% polihexanide）是一种抗阿米巴聚合物，可作用于原生动物棘阿米巴的滋养体和囊体。它作为单药治疗的滴眼液使用，采用单剂量容器包装。欧盟委员会和美国FDA均已经授予其治疗棘阿米巴性角膜炎的孤儿药资格。 此前公布的3期临床试验数据显示，接受Akantior单药治疗的患者中，84.8%的患者中位治疗时间为4个月时达到AK疾病和相关炎症消失的标准。只有3%接受治疗的患者在3期临床试验中需要接受角膜移植，此前的研究显示这一患者群体需要接受角膜移植的比例在25%以上。 ▲欲了解更多前沿技术在生物医药产业中的应用，请长按扫描上方二维码，即可访问“药明直播间”，观看相关话题的直播讨论与精彩回放 参考资料： [1] SIFI Receives European Commission Approval for AKANTIOR®. Retrieved August 26, 2024, from https://www.prnewswire.com/news-releases/sifi-receives-european-commission-approval-for-akantior-302229445.html [2] SIFI Reports Detailed Positive Results and New Data from the Completed Phase 3 Trial of AKANTIOR® in Patients with Acanthamoeba Keratitis presented at the American Academy of Ophthalmology Annual Meeting in Chicago. Retrieved August 26, 2024, from https://www.prnewswire.com/news-releases/sifi-reports-detailed-positive-results-and-new-data-from-the-completed-phase-3-trial-of-akantior-in-patients-with-acanthamoeba-keratitis-presented-at-the-american-academy-of-ophthalmology-annual-meeting-in-chicago-301647790.html 免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。 版权说明：本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。 分享，点赞，在看，聚焦全球生物医药健康创新

Regeneron has won approval in Europe for its blood cancer T-cell engager odronextamab five months after the FDA rejected the treatment under its accelerated pathway because of the timeline of its confirmatory trial. Five months after the FDA rejected Regeneron’s bid for accelerated approval of its T-cell engager odronextamab because of the immaturity of its confirmatory trial, the European Union has signed off on the treatment for two types of blood cancers.In winning the nod from the European Commission for relapsed or refractory follicular lymphoma (FL) and for relapsed or refractory diffuse large B-cell lymphoma (DLBCL), Ordspono becomes Regeneron’s first approved bispecific antibody. The endorsement covers patients who have undergone two or more lines of systemic therapy.Separately, the EC also granted a first-time approval to SIFI’s Akantior (polyhexanide), which becomes the first therapy to treat the rare corneal infection acanthamoeba keratitis. The sudden, parasitic disorder can cause blindness and primarily affects those who wear soft contact lenses. The Italian company has received orphan drug designation from the FDA for polyhexanide as a potential treatment for both acanthamoeba keratitis and fungal keratitis. Regeneron’s approval was backed by phase 1 and phase 2 trials that provided remarkable data. In the ELM-2 study, patients with FL showed an 80% overall response rate (ORR), with 73% achieving a complete response (CR). The median duration of response (DoR) for the complete responders was 25 months.In the same study, patients with DLBCL who were CAR-T therapy-naïve had a 52% ORR, with 31% reaching CR and having an 18-month median DoR.Despite the results, the FDA sent Regeneron two complete response letters in March, rejecting the company’s application for accelerated approval because its confirmatory trials for odronextamab were not yet underway. The FDA and Regeneron need to agree to timelines of the trials “prior to resubmission,” the company said.The rejection came as the FDA is wrestling with how to adjudicate accelerated approvals. With the recent failures of some FDA-sanctioned drugs, the approval mechanism has come under scrutiny. A recent study published in the Journal of the American Medical Association showed that 80% of drugs approved under the pathway couldn't demonstrate survival benefits after five years.In April, the FDA's Oncology Center of Excellence chief Richard Pazdur, M.D., addressed the issue.“If we really believe that there are no other therapeutic alternatives, then there will be obviously some degree of flexibility,” Pazdur said. “When we do see, however, that there may be accelerated approval with the same class of drugs with the same diseases and with sponsors previously having most of the confirmatory study accrual already completed at the time of accelerated approval, we have to have a level playing field for all of the pharmaceutical companies.” In the case of odronextamab, there are other new treatments from its drug class on the market in the indications. Over the last 15 months, AbbVie and Genmab’s bispecific antibody Epkinly has gained FDA nods for both FL and DLBCL. Meanwhile, Roche has two T-cell engagers on the market: Columvi earned an FDA nod in DLBCL in June, and Lunsumino was approved by the FDA as a treatment for FL in December of 2022.All the endorsements for the therapies have been for third-line use. In clinical trials, each of the companies, including Regeneron, is combining the T-cell engagers with other medicines in attempt to move them into earlier treatment lines.“Ordspono marks the first approval from our bispecific antibody platform, which we hope will increasingly contribute to our growing portfolio of practice-changing medicines for oncology and other diseases,” George Yancopoulos, M.D., Ph.D., Regeneron’s chief scientific officer, said in a release.