Boehringer Ingelheim and Lilly Report FDA’s EMDAC Outcomes for Empagliflozin (2.5mg) as Adjunct to Insulin for T1D Patients

Boehringer Ingelheim and Lilly Report FDA’s EMDAC Outcomes for Empagliflozin (2.5mg) as Adjunct to Insulin for T1D Patients

Shots:

  • The US FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted (2 out of 14) against the use of Empagliflozin 2.5 mg as an add-on to insulin therapy in patients with type 1 diabetes
  • The sNDA of Empagliflozin (2.5mg) is based on P-III EASE study assessing empagliflozin 2.5 mg + insulin vs insulin + PBO, demonstrating a 0.28% reduction in A1C with a reduction in weight (1.8 kg) and systolic blood pressure (2.1 mmHg). Empagliflozin showed the risk of diabetic ketoacidosis (DKA) in higher doses
  • Jardiance (empagliflozin, qd, 10/20mg) is an oral therapy used to lower the blood sugar level in adults with T2D and cardiovascular diseases and is contraindicated in patients with T1D and diabetic ketoacidosis

Click here to­ read full press release/ article | Ref: Eli Lilly | Image: CBS