Admelog is the first short-acting insulin approved using the FDA’s 505(b)(2) pathway.
“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease,” FDA commissioner Dr. Scott Gottlieb said in prepared remarks.
“In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways.”
Short-acting insulin products, like Admelog, are usually administered just before a meal to help stabilize blood sugar levels after eating.
“Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime,” Stefan Oelrich, EVP & head of Sanofi’s global diabetes & cardiovascular business, said in a prepared statement. “The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes.”