The first me too short acting insulin was approved today

Source: Wuxi apptec Co., Ltd on December 12, 2017, the US FDA approved the listing of short acting insulin injection admelog (insulin Lispro Injection) of Sanofi Aventis to improve the blood glucose control of adults and children over 3 years old It is worth mentioning that this is the first short-acting insulin approved as a follow-up product ("follow on" product), which is also considered as the "me too" version of short-acting insulin approved at present According to the Centers for Disease Control and Prevention (CDC), there are more than 30 million people with diabetes in the United States Their metabolism is abnormal, and their blood sugar concentration is higher than that of normal people In the long run, patients will have serious health risks, and the risk of heart disease, blindness, nerve damage, and kidney damage will increase At present, the common treatment of diabetes is insulin therapy It can control blood sugar and reduce the risk of long-term complications Admelog, approved today, is a short acting insulin product that helps diabetics control their blood sugar Generally speaking, patients can control the blood sugar level after meals by using short acting insulin before meals This kind of insulin can also be used in the insulin pump to meet the blood glucose control needs of patients during meals For type 1 diabetes patients, in order to effectively control blood sugar, short-term insulin and long-term insulin (maintain daily insulin level) are necessary One of the concerns of admelog is that it is the first short acting insulin approved for marketing through 505 (b) (2) This is a new attempt of FDA in the United States The new drugs submitted in this way will be evaluated on the basis of FDA approved new drugs or published literature Once scientifically verified, it is expected to be approved This policy aims to shorten the process of new drug development and reduce costs, so that patients can use cheaper new drugs Compared with Humalog (insulin lisproject injection), FDA of the United States thinks that the safety and effectiveness of admelog have been well verified in science Based on data from two large-scale phase 3 clinical trials, the US FDA made provisional approval for the new drug in September this year, and officially approved its launch today Dr Scott Gottlieb, director of FDA (photo source: FDA) "one of my key policies is to increase the competitiveness of the prescription drug market and help low-cost alternative drugs enter the market This is especially important for insulin, a drug used by hundreds of Americans every day and used for life to manage chronic diseases, "said Scott, FDA director "Over the next few months, we will discuss additional policies to help ensure patients continue to benefit from low-cost, safe and effective alternatives to approved drugs through FDA's shortened process," Dr Gottlieb commented "Today's approval allows us to provide patients with a choice of short acting insulin that is important and meets our safety and efficacy criteria." Said Dr Mary T Thanh Hai, deputy director of the office of new drug evaluation II of the FDA drug evaluation and research center We hope that this new drug can make more diabetic patients get effective blood sugar control!