旭化成株式会社的标志展示在该公司东京总部的入口处,日本东京,2019年10月9日摄。图片拍摄于2019年10月9日。REUTERS/Issei Kato 购买授权 公司 旭化成株式会社 10月9日 - 美国FDA周五批准了日本旭化成的药物,用于治疗某些免疫系统受损且对现有抗病毒治疗无反应的患者的持续性单纯疱疹病毒溃疡。
The logo of Asahi Kasei Corporation is displayed at an entrance of the company's Tokyo headquarters in Tokyo, Japan October 9, 2019. Picture taken October 9, 2019. Companies Asahi Kasei Corporation Oct 9 - The US FDA on Friday approved Japan's Asahi Kasei's drug for persistent herpes simplex virus sores in certain patients with weakened immune systems who have not responded to available antiviral treatments.
这种名为普利特韦的口服药物由德国制药商Aicuris开发,旭化成于4月收购了该公司。普利特韦阻断疱疹病毒复制遗传物质所需的蛋白质,阻止其增殖,使该药物能对一些对旧疗法耐药的感染起效。较老的首选药物必须经病毒酶激活后才能阻断复制,破坏这种激活的突变会导致耐药性。美国食品药品监督管理局的批准基于一项涉及101名参与者的晚期试验,其中接受普利特韦治疗的患者中有62.7%在28天内溃疡完全愈合,而接受其他治疗的患者为34%。
该试验将普利特韦与医生选择的静脉注射福司奈韦(主要获批替代药物)或西多福韦和咪喹莫德(用于超说明书用途的旧药)进行比较。试验中常见的副作用包括头痛、腹泻、恶心、食欲减退、呕吐和头晕。旭化成此前估计普利特韦可服务约1.5万名免疫系统受损的美国患者,并在2030年代中期至晚期实现超过4亿美元的峰值年销售额。
The oral drug, called pritelivir, was developed by German drugmaker Aicuris, which Asahi Kasei acquired in April Pritelivir blocks proteins the herpes virus needs to copy its genetic material, stopping it from multiplying and allowing the drug to work against some infections resistant to older treatments Older first-line drugs must be activated by a viral enzyme before blocking replication, and mutations that disrupt this activation can cause resistance The US Food and Drug Administration's approval was based on a late-stage trial involving 101 participants, in which sores healed completely within 28 days in 62.7% of patients who were given pritelivir, compared to 34% receiving other treatments The trial compared pritelivir with doctors' choice of intravenous foscarnet, the main approved alternative, or cidofovir and imiquimod — older medicines used off-label The commonly reported side effects in the trial included headache, diarrhea, nausea, reduced appetite, vomiting and dizziness Asahi Kasei had previously estimated pritelivir could serve about 15,000 US patients with weakened immune systems, and generate peak annual sales of more than $400 million in the mid-to-late 2030s