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

Regulators based the decision on outcomes trial data showing that Farxiga could cut the rate of hospitalizations by 36% among certain heart failure patients. (AstraZeneca)

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.

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RELATED: AstraZeneca's SGLT2 med Farxiga flips script on competitors with 26% CV risk cut

The newest approval is a big step forward for Farxiga, which is trailing SGLT2 rivals Invokana from Johnson & Johnson and Jardiance from Eli Lilly and Boehringer Ingelheim in terms of marketing its CV benefits. However, the label expansion is only a precursor for a bigger indication AstraZeneca is hoping to snag.

In September, Farxiga nabbed an FDA fast track designation after showing it could reduce CV risks by 26% when added to standard-of-care therapy for heart failure patients with or without Type 2 diabetes.

In that phase 3 trial, dubbed Dapa-HF, Farxiga cut the combined risk of cardiovascular death or hospitalization in heart failure patients with a reduced ejection fraction. The FDA’s expedited review will cover Farxiga’s pursuit of indications in both HFrEF and heart failure patients with a preserved ejection fraction, AstraZeneca said at the time.

If that submission leads to an FDA approval, it could be a game-changer for the SGLT2 field as a whole—and AZ is getting prepared.

RELATED: AstraZeneca aims to pump up Farxiga marketing after cardio outcomes study

In early September, the company said it planned to “increase the scope” of its Farxiga marketing. The drugmaker plans to capitalize on the strength of Farxiga’s CV results—which Kiersten Combs, AZ’s U.S. vice president of cardiovascular and metabolic disease, called “groundbreaking”—by preparing to target cardiologists, she said.

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