Sanofi's Insulin Lispro Follow-On, Admelog, Wins FDA Approval

The FDA on Monday approved Admelog, the mealtime insulin from Sanofi that is a follow-on to Eli Lilly’s Humalog (insulin lispro), for the treatment of type 1 and type 2 diabetes. The action comes after FDA had given the product tentative approval September 1, 2017.

Admelog is the first short-acting follow-on insulin to receive FDA approval; the agency previously approved Basaglar, the follow-on for Sanofi’s basal insulin, Lantus (insulin glargine, 100 units/mL). Following the arrival of Basaglar, Sanofi saw CVS Health replace Lantus with the follow-on on the 2017 formulary.

Since then, Basaglar sales have climbed: according to Market Realist, Basaglar reported revenues of $145.7 million in the third quarter of 2017, compared with $19.4 million in the third quarter of 2016.

FDA Commissioner Scott Gottlieb, MD, promised that the approval was the sign of things to come for patients. “One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” he said in a statement. “This is particularly important for drugs like insulin that are taken by millions of Americans every day for patient’s lifetime to manage a chronic disease.”

Insulin pricing has been a major policy issue in recent years. For example, the price of Humalog rose to $274.70 for a 10-ml bottle on May 2, 2017, up 7.8% from the price set in July 2016. However, insulin manufacturers report that the rebate system with pharmacy benefit managers (PBMs) means their net prices are actually going down.

As a result, the American Diabetes Association has called on Congress to investigate, and has collected signatures in support of more transparency among PBMs. All 3 major insulin makers were sued in a class action lawsuit, and Eli Lilly was singled out for a “Day of Action” on September 8, 2017, by people with diabetes and advocacy groups.

Admelog was approved quickly under FDA’s 505(b)(2) abbreviated pathway, which can be used to hold down drug development costs to keep products priced more reasonably for patients.

In a statement, Sanofi Executive Vice President and Head of Global Diabetes and Cardiovascular, Stefan Oelrich, said, “Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime.”

Besides Lantus, Sanofi has recently introduced the basal insulin Toujeo (insulin glargine, 300 units/mL).