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一次情報の記録

決定級FDA 承認

メルク、ウイルス学的に抑制されたHIV-1に対するIDVYNSOのFDA承認を取得

The document states that Merck received U.S. FDA approval for IDVYNSO, a once-daily oral treatment for certain adults with virologically suppressed HIV-1. This approval marks a new regulatory milestone for Merck's HIV franchise and expands its approved portfolio in infectious diseases. The approval is presented as a completed regulatory outcome with no further PDUFA or advisory-committee dates mentioned.

主要事実

提出
2026年4月30日 10:53
イベント
FDA 承認
方向
ポジティブ
企業
MRKMSD
アセット
IDVYNSO
出典
SEC 8-K
信頼度
出典あり
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)

出典の抜粋

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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