First Approval for Fast-Acting Lispro for Diabetes; EU OKs Oral Semaglutide

Liam Davenport

Disclosures

January 31, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for the oral form of the glucagon-like peptide (GLP-1) receptor agonist semaglutide (Rybelsus, Novo Nordisk) for adults with insufficiently controlled type 2 diabetes who seek to improve glycemic control as an adjunct to diet and exercise.

CHMP has also recommended approval of a fast-acting, or mealtime, version of insulin lispro (Liumjev, Eli Lilly) for the treatment of adults with diabetes, which is believed to be the first approval worldwide of this form of insulin lispro.

Fast-acting insulins are designed to mimic, as much as possible, the natural physiologic insulin response that occurs after meals, a process that is important for optimal A1c management. 

Mealtime, or Fast-Acting Insulin Lispro (Liumjev), Approved for Pumps

Liumjev will be indicated for use by adults with type 1 or type 2 diabetes, as part of a multiple daily injection regimen, or delivered by an insulin pump.

Lilly has also submitted approval applications for fast-acting insulin lispro in the United States and Japan.

Liumjev will compete with a fast-acting form of another insulin, aspart (Fiasp, Novo Nordisk), which was initially approved by the US Food and Drug Administration (FDA) in 2017 for the treatment of adults with diabetes; that approval did not include its use in insulin pumps. But in October, the US approval was extended to include the use of Fiasp in insulin pumps. And most recently, earlier this month, the FDA approved Fiasp for use in children.

The EU approval of Fiasp did cover its use in insulin pumps.

Oral Semaglutide Has Potential to Dramatically Change Management

The EU decision on oral semaglutide follows approval of this product by the FDA in September; Rybelsus is the first orally available GLP-1 agonist to be marketed for type 2 diabetes.

At that time, David R. Matthews, DPhil, BM, BCh, president of the European Association for the Study of Diabetes, was enthusiastic about its approval.

"I think it will dramatically change the management of [type 2] diabetes because until now GLP-1 agonists have only been available in injectable form," he told Medscape Medical News. "As soon as we've got an oral form, suddenly there will be many more people who would feel that it's perfectly acceptable to take."

Just 2 weeks ago, the FDA approved an additional indication for the IV form of semaglutide (Ozempic, Novo Nordisk) for type 2 diabetes ― reduction of cardiovascular (CV) disease risk; it also approved adding data pertaining to cardiovascular safety to the label of Rybelsus.

In its announcement, the EMA noted that the safety and efficacy of semaglutide have been studied in eight clinical trials of patients at various stages of type 2 diabetes, and compared against various other treatment options.

The most common adverse effects are gastrointestinal, such as nausea and diarrhea, with hypoglycemia potentially occurring when it is used in conjunction with insulin or a sulfonylurea.

Opinions adopted by the CHMP are sent to the European Commission and European Union (EU) for marketing authorization, which is normally a formality and is typically granted within about 60 days. Once the approval is rubber-stamped, decisions about price and reimbursement of products take place within each EU member state.

First oral GLP-1 treatment for type 2 diabetes. European Medicines Agency. Press release

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