The rapid-acting insulin received tentative approval based on its similarity to Eli Lilly's Humalog.
Sanofi announced Friday that FDA has granted tentative approval for its rapid-acting insulin lispro injection 100 units/mL, which will have the trade name Admelog if the drug becomes available.
The tentative approval is based on physicochemical, nonclinical and clinical similarity to Eli Lilly’s Humalog. The European Commission approved the product in July under the trade name Insulin lispro Sanofi.
Rapid-acting insulin is taken at mealtime. FDA tentative approval is based on a development program involving adults with type 1 and type 2 diabetes. Tentative approval means the data in the marketing application were complete to qualify for approval, but that there are unresolved patent issues.
"Sanofi is committed to broadening our portfolio of products to help people living with diabetes manage their blood sugar," Stefan Oelrich, senior vice president and head, Global Diabetes Franchise, Sanofi, said in a statement. "With this tentative approval, we are now one step closer to offering Admelog as an option for those who use rapid-acting insulin."
Research Points to Potential MCIDs in Diabetes Distress Scale–17
November 29th 2023Researchers identified a value of at least 0.25 to be a minimal clinically important difference (MCID) in diabetes distress, and MCID values of 0.38 and 0.39 for emotional and interpersonal distress subscales and physician and regimen distress subscales, respectively.
Read More
How Can Employers Leverage the DPP to Improve Diabetes Rates?
February 15th 2022On this episode of Managed Care Cast, Jill Hutt, vice president of member services at the Greater Philadelphia Business Coalition on Health, explains the Coalition’s efforts to reduce diabetes rates through the Diabetes Prevention Program (DPP).
Listen
Balancing Care Access and Fragmentation for Better Outcomes in Veterans With Diabetes
April 22nd 2021The authors of a study in the April 2021 issue of The American Journal of Managed Care® discuss the possible reasons behind the link between care fragmentation and hospitalizations in veterans with diabetes, as well as potential opportunities to address disjointed care in the context of the widespread telehealth uptake seen during the COVID-19 pandemic.
Listen