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原始来源记录

决策级FDA 批准

默沙东获得 FDA 批准 IDVYNSO 用于病毒学抑制 HIV-1 患者

该文件显示，默沙东获得美国 FDA 批准 IDVYNSO，这是一种每日一次的口服药物，用于治疗特定病毒学抑制的 HIV-1 成人患者。此项批准标志着默沙东 HIV 产品线的新监管里程碑，并扩大了其在传染病领域的获批产品组合。该批准被视为已完成的监管结果，未提及进一步的 PDUFA 或顾问委员会日期。

关键事实

申报时间
2026年4月30日 10:53
事件
FDA 批准
方向
积极
公司
MRK默沙东
资产
IDVYNSO
来源
SEC 8-K
可信度
有来源
participants 65 plus
81 (11%)
participants 75 plus
10 (1%)
trial 051 suppression
96% vs 92%
trial 052 suppression
92% vs 94%
trial 051 hiv rna ge 50
1% vs 5% (IDVYNSO vs bART)
trial 052 hiv rna ge 50
1% vs 1% (IDVYNSO vs BIC/FTC/TAF)

来源摘录

EX-99.1 2 tm2612241d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 News Release Merck & Co., Inc., Rahway, N.J., USA Announces First-Quarter 2026 Financial Results; Highlights Significant Regulatory Approvals and Clinical Milestones Sales Growth Driven by Continued Strength in Oncology and Animal Health, Plus Increasing Contributions From Launches - Total Worldwide Sales Were $16.3 Billion (5% Growth; 3% Growth ex-FX) o KEYTRUDA/KEYTRUDA QLEX 1 Sales Were $8.0 Billion (12% Growth; 8% Growth ex-FX); Includes KEYTRUDA QLEX Sales of $128 Million o WINREVAIR Sales Were $525 Million (88% Growth; 87% Growth ex-FX) o Animal Health Sales Were $1.8 Billion (13% Growth; 6% Growth ex-FX) - GAAP Loss per Share Was $1.72; Non-GAAP Loss per Share Was $1.28; GAAP and Non-GAAP Loss per Share Include a Ch

SEC 8-K

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