Endocrine Disorders Archives - MPR

Endocrine Disorders

type 1 diabetes

FDA Rejects Dapagliflozin sNDA for Type 1 Diabetes

The Food and Drug Administration has issued a complete response letter to AstraZeneca regarding the supplemental New Drug Application (sNDA) for the use of dapagliflozin (Farxiga) as an adjunct treatment to insulin in patients with type 1 diabetes (T1D), when insulin alone does not provide adequate glycemic control. In a press statement, the Company noted…