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

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

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  • 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


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