Week-long insulin will be a game-changer, when FDA approves it

Current options for insulin therapy for those with diabetes include fast acting and sustained acting insulin injections—but none last more than a day. Novo Nordisk’s insulin icodec—a weekly insulin being sold under the brand name Awiqli—has been approved for use in the EU, Canada, Australia, Japan, and Switzerland for type 1 and type 2 diabetes. It has also been approved in China for use in type 2 diabetes.

Here in the US, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted last year 7—4 against approving insulin icodec for adults with type 1 diabetes. The committee cited the increased risk of hypoglycemia from insulin icodec compared to daily insulin injections as evidence that the benefits of weekly icodec did not outweigh risks. FDA did not decide about use of insulin icodec for those with type 2 diabetes. FDA also requested additional information about the manufacturing process of insulin icodec, the specific issues have not been made public.

“Weekly insulin could drastically improve treatment adherence by reducing the burden through fewer injections,” says E. Albert Reece, M.D., Ph.D., MBA, The Distinguished University Professor and senior scientist at the Center for Birth Defects Research at University of Maryland School of Medicine and co-founder of DPSG-NA.

One of the biggest challenges to diabetes management is treatment adherence and patient consistency with injections. A longer-acting insulin could reduce the risk of blood glucose fluctuations, thus reducing the risk of longer-term diabetes complications including neuropathy, nephropathy, and retinopathy. For patients who are pregnant, a longer-acting insulin with more stably maintained blood glucose levels could better prevent certain complications including diabetic embryopathies (developmental defects associated with uncontrolled hyperglycemia).