- Advisers at the Committee for Medicinal Products for Human Use (CHMP) have recommended approval of Novo Nordisk’s Xultophy (insulin degludec/liraglutide) for treatment of type 2 diabetes.
- Allergan’s Ozurdex (dexamethasone) has been recommended for a label extension to include approval for treatment of vision loss due to diabetes macular edema (DME).
- Ozurdex is approved in the US for treatment of DME, but Xultophy is not yet FDA-approved.
According to the World Health Organization (WHO), approximately 60 million people in Europe have diabetes. Even with an ongoing R&D process underway, there continue to be many unmet medical needs associated with diabetes. DME affects 7% if patients with diabetes and is the No. 1 cause of vision loss in this population. Xultophy represents an attractive treatment option because it combines two effective medications, improves glycemic control when used with oral medication and has a neutral effect on body weight.