Date: 22-Oct-2019

AstraZeneca's Farxiga nabs first CV approval from the FDA. Will a bigger one follow

The Holy Grail for AstraZeneca’s SGLT2 med Farxiga is an approval to treat heart failure in patients with or without diabetes—and it’s well on its way to that goal. But while it waits for that game-changing win, Farxiga will take a heart-helping approval for diabetes patients. The FDA on Monday approved Farxiga to reduce the risk of heart failure hospitalizations in patients with Type 2 diabetes, the drug’s first cardiovascular approval. Regulators based the decision on outcomes trial data showing that Farxiga could 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 has the data on its label in Europe, where it's known as Forxiga