Results from the phase 3 AWARD-11 trial evaluating higher doses of dulaglutide showed superior HbA1c and body weight reductions with an investigational 4.5mg dose in patients with type 2 diabetes (T2D) compared with dulaglutide 1.5mg.
The FDA has granted Breakthrough Therapy designation to apabetalone (Resverlogix Corp) in combination with standard of care therapy, including high-intensity statins, for the secondary prevention of major adverse cardiac events (MACE) in patients with type 2 diabetes mellitus and recent acute coronary syndrome.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) voted 14 to 2 against the approval of empagliflozin 2.5 mg as an adjunct to insulin for adults with type 1 diabetes.
