FDA expands indication for Soliqua® 100/33

FDA 批准扩大2型糖尿病复方新药 Soliqua 药物的适用范围

2019-03-01 07:00:00 CISION


 The U.S. Food and Drug Administration has approved the expanded use of Soliqua® 100/33 100 Units/mL and 33 mcg/mL. Previously approved for use as an add-on to diet and exercise in adults with type 2 diabetes who are uncontrolled on long-acting insulin or lixisenatide, Soliqua 100/33 can now also be prescribed for patients uncontrolled on oral antidiabetic medicines. "Many people living with type 2 diabetes are uncontrolled on diet and exercise alone and could require additional interventions to help lower their blood sugar levels," said Michelle Carnahan, North America Head of Primary Care, Sanofi. "This FDA decision marks the first combination insulin and GLP-1 injectable medicine approved for adults living with type 2 diabetes who are uncontrolled with diet and exercise, potentially providing them access to an option that can help them achieve their treatment goals." The FDA approval was based on data from the LixiLan-O clinical trial which showed, in adults with type 2 diabetes uncontrolled with metformin and/or a second oral antidiabetic therapy, that treatment with Soliqua 100/33 led to significantly greater reductions in blood sugar levels compared with insulin glargine and lixisenatide (-1.6%, -1.3%, -0.9%, respectively; p<0.0001). In addition, significantly more patients reached their target blood sugar levels with Soliqua 100/33 (74%) compared with insulin glargine (59%) or lixisenatide (33%). Low blood sugar events were similar between Soliqua 100/33 (25.6%) and insulin glargine (23.6%), but were lower with lixisenatide (6.4%). The most common adverse events generally at the beginning of treatment in the Soliqua 100/33 arm were nausea (9.6%) and vomiting (3.2%). Sanofi will continue offering its savings program for Soliqua 100/33 which can limit out-of-pocket expenses sometimes to $0 for all commercially insured patients regardless of formulary status on an insurance plan or income level. For more information about this program, visit www.soliqua100-33.com.
美国食品药品监督管理局(Food and Drug Administration)已批准扩大 Soliqua ®100/33100单位/ mL 和33微克/mL 的使用。以前批准用于补充饮食和运动的成人2型糖尿病谁是不受控制的长效胰岛素或利西塞那肽, Soliqua 100/33现在也可以处方的患者不受控制的口服抗糖尿病药物。 Sanofi 北美初级保健主管 Michelle Carnahan 说:“许多患有2型糖尿病的人在饮食和运动方面都不受控制,可能需要额外的干预来帮助降低血糖水平。”FDA 的这一决定标志着胰岛素和 GLP-1注射用药首次被批准用于患有2型糖尿病的成年人,他们不受饮食和运动的控制,有可能为他们提供一种帮助他们实现治疗目标的选择。 FDA 的批准是基于利西兰-O 临床试验的数据,该临床试验表明,在不受二甲双胍和/或第二次口服抗糖尿病治疗控制的成人中,与甘精胰岛素和利西塞那肽相比, Soliqua 100/33治疗可显著降低血糖水平(-1.6%、-1.3%、-0.9%)。p <0.0001。此外,与甘精胰岛素(59%)或利西塞那肽(33%)相比,用 Soliqua 100/33(74%)达到目标血糖水平的患者明显增多。低血糖事件与 Solidqua 100/33(25.6%)和甘精胰岛素(23.6%)相似,但与利西塞那肽(6.4%)相似。在索洛卡100/33臂开始治疗时,最常见的不良反应是恶心(9.6%)和呕吐(3.2%)。 赛诺菲(Sanofi)将继续为 Soliqua 100/33提供储蓄计划,该计划可以将所有商业保险患者的自付费用有时限制为0美元,而不管保险计划或收入水平的规定状况如何。有关此计划的更多信息,请访问 www.soliqua100-33。com 。