EU Panel Endorses Use of 2 Diabetes-Related Products

Miriam E. Tucker


July 25, 2014

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued 2 new positive opinions for products related to the treatment of patients with diabetes.

The CHMP recommended granting market authorization for Novo-Nordisk's Xultophy, a fixed-dose (100 units/mL + 3.6 mg/mL) combination of the basal insulin analog degludec and the glucagonlike peptide-1 receptor agonist liraglutide.

The combination product lowers glucose in patients with type 2 diabetes via 2 mechanisms: insulin degludec binds specifically to the human insulin receptor, providing the same pharmacological effect as human insulin, and liraglutide enhances glucose-dependent insulin secretion and diminishes glucagon release.

"Xultophy is indicated for the treatment of adults with type 2 diabetes mellitus to improve glycemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycemic control," according to an EMA news release.

The most common adverse effects of the combination product are hypoglycemia and gastrointestinal events, including nausea and diarrhea. It has a neutral effect on body weight.

A pharmacovigilance plan for Xultophy will be implemented as part of the marketing authorization, according to a CHMP statement.

Ophthalmic Indication

In a separate decision, the CHMP also recommended a new postauthorization indication for Ozurdex, a dexamethasone formulation manufactured by Allergan Pharmaceuticals Ireland.

The newly recommended indication for Ozurdex is "for the treatment of adult patients with visual impairment due to diabetic macular edema who are pseudophakic or who are considered insufficiently responsive to or unsuitable for noncorticosteroid therapy," according to an EMA news release.

Ozurdex has already received marketing authorization for 2 other ophthalmic indications in adult patients: macular edema after either branch retinal vein occlusion or central retinal vein occlusion, and inflammation of the posterior segment of the eye presenting as noninfectious uveitis.


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