FDA批准了一种新的月度降胆固醇药物,显著降低LDL并提升了便利性。
FDA approves new monthly cholesterol drug with significant LDL reduction and improved convenience.
林业发展局批准了新月刊PCSK9抑制剂Lerodalcibep-liga(Lerochol),用于高胆固醇的成年人,包括有异性性胆固醇的家庭高胆固醇患者。
The FDA has approved lerodalcibep-liga (Lerochol), a new monthly PCSK9 inhibitor, for adults with high cholesterol, including those with heterozygous familial hypercholesterolemia.
它设计为家庭使用,单次注射,在室内温度稳定,最长3个月,方便使用。
It is designed for home use with a single subcutaneous injection, stable at room temperature for up to three months, improving convenience.
根据涉及近3 000名病人的第三阶段试验,在HEFH患者中将LDL胆固醇减少至少50%,在高危人群中减少至少60%,没有与治疗相关的严重副作用。
Based on Phase 3 trials involving nearly 3,000 patients, it reduced LDL cholesterol by at least 50% in those with HeFH and at least 60% in high-risk individuals, with no serious treatment-related side effects.
预计该药物将于2026年春季推出。
The drug is expected to launch in spring 2026.