AstraZeneca's Farxiga steps on FDA fast track toward CV outcomes nod

When SGLT2 med Farxiga scored a major cardiovascular outcomes win last month, AstraZeneca touted the drug’s trial results as a game changer for the market. Turns out the FDA likes those results, too—and it’s expediting a review of Farxiga’s CV label hopes.

Farxiga nabbed a fast-track designation from the FDA after showing a 26% CV risk reduction when added to standard of care for patients with or without Type 2 diabetes.

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

Farxiga is currently approved as a standalone and combo treatment to help control blood sugar in adults with Type 2 diabetes. In August, the drug won a separate fast-track designation as a potential treatment to fend off kidney failure and prevent CV- and kidney-related death in patients with chronic kidney disease.

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A jump-start on its FDA review could help Farxiga hold its place on top of the SGLT2 class, despite being behind the pack in terms of touting its CV benefits. And though one analyst called the Dapa-HF results a potential “class effect” for all SGLT2 inhibitors, the FDA's explicit blessing would allow AZ to market Farxiga where its rivals can't.

Earlier this month, the British drugmaker said it plans to “increase the scope” of its Farxiga marketing if and when it wins an FDA approval based on phase 3 Declare data. Those trial results, released in March, showed a 36% reduction in hospitalizations compared with placebo in diabetes patients with heart failure and a reduced ejection fraction. For patients without a reduced ejection fraction, that figure was 24%.

In tandem with the Dapa-HF results, Kiersten Combs, AZ’s U.S. vice president of cardiovascular and metabolic disease, said the drugmaker plans to capitalize on the strength of Farxiga’s CV results—which she called “groundbreaking”—by preparing to target cardiologists.

“There is a future in the CV space and really being able to engage in a conversation with cardiologists is a part of our future strategy,” she said. AZ expects a decision on the Declare results late this year.

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With a speedy review for its CV benefits upcoming, Farxiga will look to take its place on top of the SGLT2 market in treating heart failure patients. Unfortunately for the competition, Farxiga already has the lead in sales.

In the second quarter, Farxiga hit $377 million in sales compared with $232 million in revenue for Eli Lilly and Boehringer Ingelheim’s Jardiance and $177 million for Johnson & Johnson’s Invokana.

Jardiance was the first SGLT2 to successfully show—and market—CV benefits after the FDA approved the findings of a 2015 study dubbed Empa-Reg, which showed a 14% reduced risk of major cardiovascular events in Type 2 diabetes patients.

Invokana, for its part, scored an FDA approval in October for reducing major CV events in high-risk Type 2 diabetes patients—a one-of-a-kind approval in the class.