Sanofi’s first short-acting insulin, Admelog receives FDA approval
Date: 2017-12-12   Author: Pankaj Singh  Category: #news

Sanofi’s first short-acting insulin, Admelog receives FDA approval

The U.S. FDA has approved first short-acting insulin, Admelog to control increasing risk associated with diabetes. After several clinical trials on Admelog from September 2017, FDA has now granted the final approval to this diabetes treatment drug, which improves blood sugar levels in adults with type 2 diabetes, children aged 3 years, and the elderly with diabetes mellitus of type 1.

As per the estimates by CDC (Center for Disease Control and Prevention), more than 30 million people across the United States suffer from diabetes, which tends to increase the risk of serious health issues such as kidney damage, heart disease, blindness. The risk associated with these long-term complications can be reduced with insulin treatment, which seems to have been the base of the aforementioned discovery, as per sources.

Reliable reports state that the new drug approval application could be sanctioned through 505 (b)(2) pathway, commonly called as Federal Food, Drug, and Cosmetic Act. The new drug approval may also depend on FDA’s approval of similar drugs earlier. The use of such pathways is likely to reduce the overall development cost associated with products, which may be supplied to the patients at a lower cost, state sources.

The deputy director of FDA’s New Drug Evaluation II, Mary T. Thanh Hai has stated that they were approving a short-acting insulin drug for patients as per the required safety and effectiveness standards. The scientific data associated with Admelog includes two phase 3 clinical trials for which approximately 500 patients had enrolled.

Reports cite that in the clinical trials, the research team of FDA had found certain adverse reactions associated with the intake of Admelog such as rashes, itching, and hypoglycemia. Allergic reactions, thickening or thinning of fatty tissue, and adverse reactions at injection site are also other implications of Admelog, claims the FDA report.

Reportedly, caregivers and patients have been advised by the FDA to check the blood glucose level before being treated with insulin products, to prevent the onset of any other complication due to Admelog.



About Author


Pankaj Singh

Pankaj Singh

Pankaj Singh Develops content for Algosonline, Market Size Forecasters, and a couple of other platforms. A Post Graduate in Management by qualification, he worked as an underwriter in the UK insurance domain before deciding to switch his field of profession. With exp...

Read More

More from Pankaj


Post Recommendents

Global Luxury Interior Design Market - Growth, Trends and Forecast (2020 - 2025)
Author: Sachin Pashte

MarketStudyReport.com adds Global Luxury Interior Design Market research focusing on the major drivers and restraints for the key players. It also provides analysis of the market share, segmentation, revenue forecasts and geographic regions of the...


Financial Wellness Program Market: Global Demand Analysis & Opportunity Outlook 2025
Author: Sachin Pashte

Market Study Report adds New Global Financial Wellness Program Market research providing in-depth information about market overview, top vendors, Key market highlights, product types, market drivers, challenges, trends, Financial Wellness Program ...


Misting Systems Market Trends and Prospects by 2025
Author: Sachin Pashte

Misting Systems market report gives attention to market segmentation, market size, and forecast of 2020-2025 to help stakeholders in making a good decision for the future investments. Misting Systems industry report segmented into types, applicati...