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AstraZeneca's Farxiga granted fast track status for heart failure treatment

September 16, 2019

By Reuters Staff

(Reuters) - AstraZeneca Plc said on Monday the U.S. Food and Drug Administration (FDA) had granted Fast Track designation for the development of its diabetes drug Farxiga (dapagliflozin) to reduce the risk of cardiovascular death, or the worsening of heart failure, in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF).

The grant comes after AstraZeneca made strides last month towards its goal of adding heart failure to the conditions that can be treated by Farxiga, putting it ahead of a rival treatment from Eli Lilly.

The FDA's fast track programme is designed to speed up the development and review of new medicines for the treatment of serious conditions where there is an unmet need.

Farxiga, already approved as a treatment for type-2 diabetes, is part of the SGLT2-inhibitor class of antidiabetics that cause the kidneys to expel blood sugar from the body through urine.

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