U.S. FDA Gives Fast Track Status to Dapagliflozin for Patients With Chronic Kidney Disease

By Reuters Staff

August 28, 2019

(Reuters) - AstraZeneca Plc said on Tuesday that the U.S. Food and Drug Administration has granted fast track status for the development of its diabetes drug Farxiga (dapagliflozin) to prevent heart and kidney failure in patients with chronic kidney disease (CKD), with and without diabetes.

Farxiga, one of AstraZeneca's top 10 drugs by sales, is part of the SGLT2-inhibitor class of antidiabetics that cause the kidneys to expel blood sugar from the body through urine.

In July, U.S. regulators declined to approve Farxiga as a supplement to insulin in adults with type-1 diabetes where insulin alone was not able to control blood sugar levels.

The treatment is already approved in the U.S. to treat type 2 diabetes, the more common form of the condition.

Farxiga competes with rival diabetes drugs, including Eli Lilly and Boehringer Ingelheim's Jardiance and Novo Nordisk's Victoza.

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