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

AstraZeneca's Farxiga showed positive data in reducing cardiovascular risks in a new outcomes trial. (AstraZeneca)

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.

RELATED: ACC: AstraZeneca's Farxiga chops follow-up CV events by 16% in heart attack patients with diabetes

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.

RELATED: FDA fast-tracks BI, Lilly's Jardiance in chronic heart failure

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.

RELATED: AstraZeneca's Farxiga follows rival Zynquista to FDA rejection in Type 1 diabetes

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.

Suggested Articles

Besides paying $729 million to settle notorious kickback allegations, Novartis has promised to put strict restrictions on its future speaker programs.

Pharma companies including Pfizer and Novartis paused advertising on Facebook for July to protest hate and disinformation on the platform.

CureVac and Tesla are teaming up to produce the German vaccine maker's molecular RNA printers, Tesla CEO Elon Musk tweeted Thursday.