相关临床试验
119
57 进行中
药物批准
0
批准总数
监管机构
0
监管机构数
成立时间
N/A
进行中（未招募）
57
47.9%
已完成
50
42.0%
招募中
2
1.7%
终止
5
4.2%
撤回
5
4.2%
暂无批准数据
- Novartis has received FDA approval for Leqvio (inclisiran), a first-in-class siRNA therapy that reduces LDL cholesterol with just two injections per year. - The drug achieved up to 52% LDL cholesterol reduction in phase 3 trials when added to statins in patients with high cholesterol and atherosclerotic cardiovascular disease. - Approximately 16 million Americans with ASCVD taking statins are not reaching their recommended LDL cholesterol targets, representing a significant market opportunity. - The approval comes after a one-year delay due to manufacturing facility issues, with Novartis transferring production to its own Austrian facility.
- Novartis has established a groundbreaking population health management agreement with NHS England to provide inclisiran access to approximately 300,000 high-risk cardiovascular patients over three years. - The collaboration follows NICE's positive recommendation and represents the first-of-its-kind approach to proactively identify and treat eligible patients with atherosclerotic cardiovascular disease across England. - Inclisiran, a twice-yearly siRNA therapy that demonstrated over 50% LDL cholesterol reduction in Phase III trials, will be administered in primary care settings to patients with persistently elevated cholesterol despite maximum statin therapy.
