After scoring its first FDA nod as a treatment for heart failure patients three short months ago, AstraZeneca’s Farxiga had its sights set on a game-changing approval in patients with or without diabetes. Monday, the FDA gave the SGLT2 med another push toward that goal.
The FDA granted Farxiga a priority review for reducing the risk of cardiovascular events in certain heart failure patients with or without Type 2 diabetes, a potential first in the SGLT2 class, AstraZeneca said.
Farxiga is currently approved to reduce the risk of hospitalizations in heart failure patients with a reduced ejection fraction (HFrEF) and Type 2 diabetes, as well as solo and combo approvals in diabetes proper.
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The heart failure nod, granted in October, was based on outcomes trial data showing Farxiga cut the rate of hospitalizations by 36% among heart failure patients with a reduced ejection fraction and by 24% among those without one.
Farxiga already sports those benefits on its label in Europe, where it’s known as Forxiga.
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