FDA批准首款每月一次皮下注射奥氮平Weltruza：成人精神分裂症治疗免负荷剂量、免注射后观察
梯瓦制药（Teva）10月9日宣布，美国食品药品监督管理局（FDA）已批准Weltruza（奥氮平）缓释注射混悬液，用于治疗成人精神分裂症。这是首款、也是目前唯一一款每月一次皮下注射的奥氮平长效制剂。
奥氮平是沿用30多年的精神分裂症基础药物，但每天口服对不少患者是坚持治疗的难关。Weltruza的给药方式不同：每月到医疗机构皮下注射一次即可，不需要起始负荷剂量，不需要在治疗初期配合口服奥氮平，也不需要注射后留院观察。产品有318毫克、425毫克和531毫克三种规格，分别对应每日口服奥氮平10毫克、15毫克和20毫克的剂量。该药采用MedinCell公司的SteadyTeq共聚物缓释技术。
批准依据是三期SOLARIS试验：一项多国、随机、双盲、安慰剂对照研究纳入675名18至64岁的成人患者，在8周安慰剂对照期中，Weltruza组症状评分的改善显著大于安慰剂组。霍夫斯特拉大学Zucker医学院精神病学临床教授Christoph Correll说，新制剂无需口服配合、负荷剂量或加强注射就能达到治疗血药浓度，「可以帮助患者、照护者，也为临床医生提供一件重要的新工具」。梯瓦首席医学官Eric Hughes说，免除每次注射后的观察要求，拆除了长效针剂治疗的一道重要门槛。
需要注意的是，Weltruza带有黑框警告：患痴呆相关精神病的老年人使用抗精神病药死亡风险增加，该药未获批用于这一人群。梯瓦预计产品未来几周内在美国上市。
FDA Approves Weltruza, the First Once-Monthly Subcutaneous Olanzapine for Adults With Schizophrenia
Teva Pharmaceuticals announced on October 9 that the U.S. Food and Drug Administration has approved Weltruza (olanzapine) for extended-release injectable suspension for the treatment of schizophrenia in adults. It is the first and only once-monthly subcutaneous injectable formulation of olanzapine.
Olanzapine has been a foundational schizophrenia treatment for more than 30 years, but sticking with a daily pill remains a major barrier for many patients. Weltruza is given once a month by subcutaneous injection and requires no loading dose, no supplemental oral olanzapine at the start of treatment and no post-injection monitoring. It will be sold in 318 mg, 425 mg and 531 mg strengths, corresponding to daily oral olanzapine doses of 10 mg, 15 mg and 20 mg. The product uses SteadyTeq, a copolymer sustained-release technology developed by MedinCell.
The approval rests on the Phase 3 SOLARIS trial, a multinational, randomized, double-blind, placebo-controlled study of 675 adults aged 18 to 64. In the eight-week placebo-controlled phase, Weltruza produced significantly greater improvement in symptom scores than placebo. Christoph Correll, clinical professor of psychiatry at the Zucker School of Medicine at Hofstra/Northwell, said the new option achieves therapeutic blood levels without oral cotreatment, loading doses or booster injections and "can help empower patients, support their care partners and provide clinicians with an important new tool." Teva's chief medical officer, Eric Hughes, said eliminating the need for monitoring after each injection removes a significant barrier to long-acting treatment.
Weltruza carries a boxed warning for an increased risk of death in older adults with dementia-related psychosis and is not approved for that population. Teva expects the product to become available in the United States in the coming weeks.
来源：GSM·美国（原文链接）
图片来源：皮下注射剂（资料图）。Whispyhistory 摄，CC BY-SA 4.0，经 Wikimedia Commons。 / A subcutaneous injection product (file photo). Photo by Whispyhistory, CC BY-SA 4.0, via Wikimedia Commons.
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