Despite Farxiga's earlier debut in heart failure, AstraZeneca’s SGLT2 med has been playing regulatory catch up to Eli Lilly and Boehringer Ingelheim’s Jardiance. Thursday, AZ unveiled a phase 3 win for the drug that could help close the gap.
In the late-stage Deliver study, Farxiga delivered a statistically significant and clinically meaningful reduction in the primary composite endpoint of cardiovascular death or worsening heart failure compared with placebo, AstraZeneca said in a release. Specifically, AZ’s trial looked at heart failure patients with mildly reduced or preserved ejection fraction. Farxiga is already approved for heart failure with reduced ejection fraction (HFrEF).
In HFrEF, the heart muscle doesn’t contract properly. For patients with heart failure with preserved ejection fraction (HFpEF), the muscle contracts properly, but the ventricles don’t relax. Both conditions affect the heart’s ability to pump enough blood.
The results, paired with earlier findings from the Dapa-HF trial, "show that Farxiga is effective in treating heart failure regardless of ejection fraction,” AZ's R&D chief Mene Pangalos said in a statement.
The British drugmaker plans to disclose full data at an upcoming medical meeting and says it will make regulatory submissions “in the coming months.”
If Farxiga can win a label expansion into HFpEF, then it will match rival Jardiance's heart failure approval. That drug in February won a label expansion to curb the risk of cardiovascular death and hospitalization in heart failure patients regardless of their ejection fraction status.
Farxiga is also approved in type 2 diabetes and chronic kidney disease (CKD). The med's safety and tolerability in Deliver looked good and proved consistent with its known profile, AstraZeneca said.
Despite Jardiance’s heart failure indication lead, Farxiga’s star is rising. In the first three months of 2022, Farxiga for the first time reached $1 billion in quarterly sales, AZ said last month.
Aside from growing demand in its established diabetes, heart failure and CKD niches, Farxiga got a boost from recent guideline updates from cardiology societies, AZ said.
In heart failure specifically, Farxiga and Jardiance are neck-and-neck on market share at about a 50-50 split, Ruud Dobber, AZ’s biopharmaceuticals business head, told investors on an earnings call in April. Outside the U.S., meanwhile, Farxiga has the lead in several countries thanks to its earlier market debut, Dobber added.
Lilly, for its part, posted $1.49 billion in Jardiance sales for all of 2021, while Boehringer Ingelheim recorded 3.9 billion euros ($4.6 billion) in revenues from the drug. Under the partners' diabetes collaboration, Lilly receives a royalty on BI's sales in the "most significant markets," the company said in its latest annual report.
For all of 2021, Farxiga snared a little more than $3 billion, AstraZeneca said in its earnings report published in February.