After stopping Farxiga trial early, AstraZeneca declares success in CKD treatment
Back in March, AstraZeneca announced plans to halt a Phase III trial for its Farxiga drug ahead of schedule after seeing “overwhelming efficacy” in patients with chronic kidney disease. Now, the British drugmaker is claiming a win after the drug met all primary and secondary endpoints.
The trial confirmed Farxiga, an SGLT2 inhibitor used to treat adults with type 2 diabetes, helped halt kidney disease progression. AstraZeneca tracked a composite primary endpoint that combined measurements on whether renal function improved and whether the drug reduced the risk of renal failure. The trial hit that endpoint.
Additionally, patients saw improvements regardless of whether they had type 2 diabetes, potentially giving it a leg up on SGLT2 competitors from J&J and Eli Lilly. That’s a treatment population of about 30 million people just in the United States.
As is protocol, AstraZeneca will release full trial data at a later date, setting up some drama with how exactly it will compare to its rivals. This year has already been a boon for Farxiga, as the drug received an FDA OK in May to reduce the risk of CV death and hospitalization for heart failure in patients with or without type 2 diabetes.
J&J’s Invokana had been the leader of the SGLT2 field before getting hit with a black box warning in 2017 for an increased risk of amputations. But the drug got the green light for those with CKD last year, securing a lifeline and rebounding from a sharp decrease in sales.
Eli Lilly’s Jardiance further crowds the market with its own fast-track program for CKD, though it has not yet received FDA approval. Farxiga was slightly ahead in this regard, as regulators granted it fast-track status last year.
This field of inhibitors targets a protein in the kidneys that regulates how the organs reabsorb glucose. By blocking the SGLT2 protein, the drugs lower reabsorption and consequently lower blood sugar levels. Invokana was the first to hit shelves back in 2013, with Jardiance and Farxiga following suit the next year. All three have netted billions of dollars in combined sales over the years, with Farxiga topping competitors in 2019 at $1.54 billion.
However, when the pharma companies have attempted to expand use of these drugs to type 1 diabetes, they have typically not succeeded. AstraZeneca, Eli Lilly and Sanofi have all been shot down by the FDA in such expansions due to a higher risk of developing diabetic ketoacidosis, in which the body switches to burning fats when short on insulin.