AstraZeneca's Farxiga pads its case for new heart-helping approval

AstraZeneca is still stinging after its SGLT2 diabetes drug Farxiga was waved off by the FDA in Type 1 disease. But here's something that could ease the pain: New outcomes data showing Farxiga cut cardiovascular risks in heart failure patients—with or without diabetes.

In a phase 3 trial, Farxiga cut the risk of cardiovascular death or hospitalization in patients with reduced ejection fraction (HFrEF), when added to standard treatments for heart failure. The data could help Farxiga score a CV risk-reduction approval, a distinction its rivals in the SGLT2 class already have.

The trial, dubbed Dapa-HF, was the first to test an SGLT2 drug against heart failure in patients with or without Type 2 diabetes, the company said. It pitted Farxiga plus standard therapy against standard therapy alone.

AstraZeneca plans to take the data to regulators "as soon as possible," Mene Pangalos, EVP of BioPharmaceuticals R&D, said in a statement.

The new data add to Farxiga's case in heart failure patients. In March, a separate outcomes trial showed the drug cut hospitalization rates by 36% in HFrEF patients and by 24% in those without a reduced ejection fraction, which measures the heart's ability to pump blood. The study also showed Farxiga lowered the rate of a second CV event by 16%.

But despite leading the SGLT2 class saleswise, Farxiga trails behind competitors like Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance in the CV indication department. And the latter is already in the FDA's express lane for a heart failure approval.

In June, Jardiance received an FDA Fast Track designation as a treatment for reducing the risks of cardiovascular death and hospitalization for heart failure among chronic heart failure patients.

It would be the drug's second CV outcomes approval; Jardiance first set itself apart in the SGLT2 class after its landmark Empa-Reg study showed a 14% reduced risk of major CV events in Type 2 diabetes patients. It won a CV risk-reduction approval from the FDA based on that data.

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.

Besides giving AZ hope for a new indication, the newest trial win should be a salve after the FDA knocked Farxiga back in Type 1 diabetes.

In July, the FDA rebuffed the drug as an add-on treatment for Type 1 adults whose insulin therapy isn't enough to control their blood sugar levels. AstraZeneca didn’t provide any details about the denial or a timeline for resubmitting its application.

It wasn’t a promising sign, but did reflect the SGLT class’ trouble reaching approval in Type 1 after another rival, Lexicon Pharmaceuticals’ Zynquista, also lost out on an FDA nod.

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