FDA Greenlights AstraZeneca’s Blockbuster Drug for Chronic Kidney Disease

AstraZeneca’s Farxiga (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is a multifaceted drug previously approved for type 2 diabetes and heart failure indications in the US. Last May the FDA had cleared the drug for treating patients affected by heart failure with reduced ejection fraction (HFrEF).

On April 30th, the blockbuster drug notched yet another approval, this time to treat chronic kidney disease (CKD). “Today’s approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years,” said Menelas Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca.

CKD is a condition that affects approximately 700 million people globally and is characterized by the progressive loss of kidney function over time. This results in several complications such as high blood pressure, anemia, and nerve damage. Besides, patients also experience an increased risk of cardiovascular events like heart failure and premature death. Diabetes, hypertension, and glomerulonephritis are all common causes of CKD.

In its latest FDA authorization, the oral Farxiga tablets are approved to reduce the risk of

1. Sustained estimated glomerular filtration rate (eGFR) decline
2. End-stage kidney disease (ESKD)
3. Cardiovascular (CV) death, and
4. Hospitalization for heart failure (hHF) in adults with chronic kidney disease (CKD) at risk of progression

“We’ve shown impressive efficacy for Farxiga in type-2 diabetes, heart failure with reduced ejection fraction and, most recently, chronic kidney disease, and we are thrilled to be able to bring this medicine to millions of patients in the US” Pangalos added.

DAPA-CKD Trial

The approval was based on impressive results from the DAPA-CKD trial that tested the efficacy of Farxiga in improving renal function and reducing the risk of cardiovascular death in patients. In the Phase 3 study, 4,304 CKD patients were randomly assigned to receive either Farxiga or placebo.

Data demonstrated that as compared to placebo, Farxiga plus the standard-of-care treatment met the primary composite endpoint. The drug reduced the relative risk of worsening of renal function, the onset of ESKD, or the risk of CV or renal death by 39%.

“Based on the unprecedented results of the DAPA-CKD trial, dapagliflozin is now the first SGLT2 inhibitor approved for the treatment of chronic kidney disease regardless of diabetes status. This transformational milestone provides patients and physicians with a new and effective treatment option for this often debilitating and life-threatening disease,” said Prof. Hiddo L. Heerspink of University Medical Center Groningen, who was the co-chair of the trial.

Competition

Farxiga was the fourth best-selling drug in 2019, raking in $1.543 billion for AstraZeneca. That number further increased to $1.964 billion in 2020. In contrast, SGLT2 Inhibitors, Jardiance (Eli Lilly and Boehringer Ingelheim) and Invokana (Johnson & Johnson), the two notable rivals of Farxiga, registered sales of $1.154 billion and $795 million, respectively in 2020.

Invokana, a Type 2 diabetes drug, is already FDA approved for Diabetic Kidney Disease (DKD), but Jardiance is still evaluated in ongoing trials for kidney diseases. With its latest approval for CKD regardless of diabetes status, Farxiga stands a good chance to further surpass its competition for quite some time.

What’s more, based on interim data from its Phase 3, DECLARE-TIMI 58 trial, AstraZeneca has reported that Farxiga is also likely to be effective in patients with less advanced CKD.

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Author

Rajaneesh K. Gopinath