FDA Gives Final Approval to Sanofi's Insulin Lispro Injection (Admelog)

The US Food and Drug Administration (FDA) has announced its approval of insulin lispro injection Admelog as a “follow-on” product, indicated to help improve glycemic control in adults and pediatric patients aged 3 years and older.

It is the first fast-acting insulin to be approved as a follow-on product. The therapy’s approval gives it an indication for adults with both type 1 (T1D) and type 2 diabetes (T2D), and children with T1D.

The Sanofi-Aventis US product received tentative approval on September 1, 2017, and was submitted via the FDA’s abbreviated 505(b)(2) pathway, allowing for data from the established literature to be used for previously approved drugs to gain additional approvals.

The FDA concluded that the insulin lispro injection met all regulatory requirements for approval in the US, but the approval in September was granted tentatively due to possible patent issues that were being resolved at the time.

Admelog was approved based on findings for Eli Lilly and Company’s insulin lispro injection Humalog, which utilized Admelog for its clinical trial data. That data included 2 phase 3 trials.

“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 Scott Gottlieb, MD, said in a statement. “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.”

The drug is administered subcutaneously via injection or infusion, or intravenously. The most common adverse reactions were hypoglycemia, itching, and rash.

“With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” Mary T. Thanh Hai, MD, the deputy director of the Office of New Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a statement.

A press release was made available.

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