AstraZeneca scores speedy FDA review for Farxiga based on 'innovative' heart attack trial design

AstraZeneca has already taken impressive Farxiga heart failure outcomes results and parlayed them into a watershed approval. Looking at Farxiga's future in a competitive heart failure market, the company is betting on innovation—and that commitment has caught the FDA's eye.

The FDA will fast track its review of SGLT2 inhibitor Farxiga to reduce the risk of heart failure hospitalization or death after a heart attack based on the drug's "innovative" registry-enrolled phase 3 trial, AstraZeneca said Thursday.

Farxiga's Dapa-MI study will integrate patient registries into a randomized, double-blind trial—by allowing doctors and registered patients to self-enroll in the study—and conduct testing at routine care sites rather than hard-to-reach trial centers.

The study will enroll heart attack patients without Type 2 diabetes, AstraZeneca said. Farxiga scored an FDA nod in May to reduce CV risks in heart failure patients with a reduced ejection fraction (HFrEF) regardless of whether they have Type 2 diabetes—a first-in-class approval.

AstraZeneca's study is the first of its kind to seek a regulatory approval based on a "pragmatic, innovative approach (that) delivers rigorous safety and efficacy data, while reducing patient burden and streamlining trial delivery," biopharma R&D head Mene Pangalos said in a release.

The study will be run in collaboration with the U.K.'s Uppsala Clinical Research Center and Myocardial Ischaemia National Audit Project. AstraZeneca hopes to begin enrollment in the fourth quarter.

The British drugmaker's novel approach to studying heart attack patients comes as a massive Farxiga outcomes study continues to bear fruit in an increasingly competitive heart failure field.

RELATED: ADA: AstraZeneca's Farxiga cuts risk of diabetes onset in heart failure patients

In June, the company unveiled a subanalysis of its Dapa-HF outcomes trial showing Farxiga cut the risk of diabetes onset in HFrEF patients with or without diabetes.

Farxiga reduced patients' chance of developing diabetes by 32%, backing up data crucial to Farxiga's landmark May approval that showed AstraZeneca's drug cut CV risks by 26% in HFrEF patients.

Since the drug's approval, AstraZeneca has seen a "rapid uptake in the cardiology space,” Kiersten Combs, AstraZeneca's VP of cardiovascular and metabolic disease, said in June.

Farxiga is also pursuing nods in heart failure patients with a preserved ejection fraction—an indication currently without an approved therapy—and chronic kidney disease, another blockbuster potential market.

RELATED: Novartis' Entresto gains steam with cardiologists despite stinging heart failure trial flop

But Farxiga's run to the top won't go unchallenged: The drug is facing competition from fellow SGLT2 inhibitors in Eli Lilly and Boehringer Ingelheim's Jardiance and Johnson & Johnson's Invokana.

Meanwhile, the heart failure space is currently dominated by Novartis' Entresto, a drug that has picked up steam among cardiologists despite a costly trial flop last year.

Key cardiologist opinion leaders have developed an overall positive view of Entresto's clinical efficacy in HFrEF patients and a consensus opinion that the drug's uptake will rapidly build in the coming years as physicians grow more comfortable prescribing it to patients, SVB Leerink analysts said in a Wednesday note to clients.

Leerink estimated that between 15% and 20% of HFrEF patients are currently treated with Entresto, and they expect that figure to "grow more rapidly" in the coming years. Entresto posted $569 million in first-quarter sales, up 62% from the same time period in 2019. Analysts have pegged the drug's 2025 sales at $4 billion.

RELATED: AstraZeneca's Farxiga scores landmark FDA nod in heart failure patients with or without diabetes

Meanwhile, AstraZeneca was pretty close behind in terms of sales at $407 million in the first quarter. The way the cardiologists see it, though, uptake in heart failure could take a while to develop and help Novartis build a lead.

Heart docs told Leerink that Farxiga's heart failure results were "impressive" and could secure a spot for AstraZeneca's drug—and maybe the rest of the SGLT2 class—as a standard-of-care add-on to Entresto.

Even better for Farxiga, what cardiologists described as a "resistance" to SGLT2s from endocrinologists isn't much of an issue for heart failure prescribers. Leerink's specialist predicted that heart failure patients with diabetes would most likely be referred to cardiologists who "prefer" using SGLT2s to manage patient outcomes.