Diabetes new drug delivery! Sanofi launches new type 2 diabetes compound Soliqua 100/33 in the US
January 11, 2017 Source: Bio Valley
Window._bd_share_config={ "common":{ "bdSnsKey":{ },"bdText":"","bdMini":"2","bdMiniList":false,"bdPic":"","bdStyle":" 0","bdSize":"16"},"share":{ }};with(document)0[(getElementsByTagName('head')[0]||body).appendChild(createElement('script')) .src='http://bdimg.share.baidu.com/static/api/js/share.js?v=89860593.js?cdnversion='+~(-new Date()/36e5)];January 5, 2017 / Bio Valley BIOON / -- French pharmaceutical giant Sanofi (Sanofi) recently announced the launch of the diabetes compound new drug Soliqua 100/33 (insulin glargine & lixisenatide, insulin glargine [100 units / ml] in the US market ] & lixisenatide [33 μg/ml]), which is an injectable drug, once daily, for basal insulin (less than 60 units per day) or lixisenatide treatment is still not adequately controlled Adult patients with type 2 diabetes with blood glucose levels account for approximately 50% of all patients with type 2 diabetes.
Soliqua 100/33 was approved by the US Food and Drug Administration (FDA) in November 2016 for a fixed dose of basal insulin glargine (100 U/mL) and a glucagon-like peptide-1 (GLP) -1) A diabetic compound drug consisting of the receptor agonist lixisenatide (lixirabide, 33 mcg/mL), and two of them have complementary hypoglycemic effects. Among them, basic insulin glargine acts on fasting blood glucose, while lixisenatide acts on postprandial blood glucose, both of which help to reduce glycated hemoglobin (HbA1c) levels. Sanofi said Soliqua 100/33 will meet the unmet medical needs of adults with type 2 diabetes who are considering starting or strengthening insulin therapy.
The approval of Soliqua 100/33 was based on data from two Phase III clinical studies. The two studies involved more than 1900 patients with type 2 diabetes who had poor glycemic control after oral hypoglycemic agents and basal insulin therapy. The efficacy and safety of Soliqua 100/33 was investigated in the study. The data showed that both studies reached the primary end point, and a significantly higher proportion of patients in the Soliqua 100/33 treatment group achieved a blood glucose level of less than 7% at the 30th week of treatment compared with the time-lapse treatment group ( 55% vs 30%).
In addition, a new post hoc analysis published in September last year showed that a higher proportion of patients in the Soliqua 100/33 treatment group achieved a daily postprandial blood glucose goal (PPG ≤ 7.8 mmol/L) compared with the time-lapse treatment group. Data were statistically significant: the proportion of patients who achieved PPG goals 0.5 h postprandial (41.4% vs 25%, p<0.0001), and the proportion of patients achieving PPG goals 1 h after meal (30.7% vs 8.3%, p<0.0001), The proportion of patients achieving PPG goals 2 h after meal (33.6% vs 5.4%, p<0.0001). Controlling blood glucose during meals is an important part of maintaining overall glycemic control and plays an important role in helping patients control their condition. The new post-mortem analysis data further supports the potential of Soliqua 100/33 in the clinical treatment of type 2 diabetes, not only to better control the level of glycated hemoglobin (HbA1c), but also to better control its meal time. Blood sugar levels.
It is worth mentioning that the FDA approved another diabetes compound Xultophy (insulin degludec/liraglutide, Degutin/Lilaru from Novo Nordisk at the same time as the Sanofi Soliqua 100/33 was approved. Peptide), a compound of the long-acting insulin insulin degludec and the GLP-1 analogue liraglutide, is administered once daily. Novo Nordisk has plans to introduce Xultophy to the US market in the second quarter of 2017. It is foreseeable that in the US market, the two sides will soon set off a new fierce battle.
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