AstraZeneca’s Farxiga is already getting a speedy FDA review as a treatment for chronic kidney disease (CKD), but it’s still piling on the positive results.
A new analysis of the company’s Declare-Timi 58 trial, presented Monday at the American Diabetes Association’s virtual annual meeting, showed the drug could reduce the proportion of patients with fast-declining estimated glomerular filtration rate (eGFR), a common measure of kidney function.
Among patients taking Farxiga in the study—which enrolled those with Type 2 diabetes as well as established or increased risk for cardiovascular disease—26.8% saw their eGFR levels decline rapidly, versus 37.1% of patients on placebo. And that benefit held across subgroups, with the drug reducing risks across a broad cut of patients, AstraZeneca said.
The data only back up Farxiga’s case as it waits for an FDA decision on its kidney disease bid. In March, the British drugmaker stopped its phase 3 Dapa-CKD trial after an interim look showed the drug was providing benefit “earlier than originally anticipated,” as AstraZeneca put it.
“This is what gets me excited about the future,” said Kiersten Combs, AstraZeneca's VP of cardiovascular and metabolic disease. Many Type 2 diabetes patients have either kidney disease, cardiovascular disease or another type of metabolic disease, so “the vision of being able to treat the patient at the center is really our mission.”
“I think the scientific data is reading out to support the importance of treating these patients with comorbidities,” she said.
Of course, the company is also hoping Farxiga will be able to treat more patients without diabetes, too. Only about half of patients in the Dapa-CKD trial had diabetes as well as CKD, and “we are anticipating the data to read out to benefit patients both with and without diabetes who suffer from chronic kidney disease,” Combs said.
Farxiga already has a nod to treat some non-diabetic patients, thanks to a May green light in heart failure with a reduced ejection fraction. U.S. regulators cleared the drug in patients both with and without diabetes, marking a first for Farxiga’s class of SGLT2 inhibitors.
Meanwhile, Farxiga is not alone in its pursuit of a kidney disease approval. Back in March, the FDA gave Eli Lilly and Boehringer Ingleheim’s Jardiance its fast-track designation as a treatment for reducing kidney disease progression and cardiovascular death in CKD patients.
Johnson & Johnson’s Invokana, for its part, won the class’ first CKD nod last September with a go-ahead to treat CKD and reduce the risk of hospitalization for heart failure in patients with Type 2 diabetes and CKD.