AstraZeneca's Farxiga Picks Up Another FDA Approval

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Thanks to a new regulatory win, AstraZeneca’s Farxiga (dapagliflozin) can now be used to reduce the risk of hospitalization for heart failure in type 2 diabetes patients with cardiovascular disease and with certain risk factors.

This morning, AstraZeneca announced the U.S. Food and Drug Administration (FDA) granted Farxiga another approval for this indication. The approval was granted based on results from the landmark DECLARE-TIMI 58 CV outcomes trial, which evaluated type 2 diabetes patients with multiple cardiovascular risk factors or established cardiovascular disease. Farxiga has previously been approved as a monotherapy and as a combination treatment to improve blood sugar control in type 2 diabetes.

SLG2 inhibitors, such as Farxiga, Merck’s Steglatro, Johnson & Johnson’s Invokana and Eli Lilly and Boehringer Ingelheim’s Jardiance, allow diabetes patients to excrete excess glucose through their urine.

The FDA’s approval marks the first time an SGLT2 inhibitor has been cleared in the United States to reduce the risk of hospitalization for heart failure in type 2 diabetes patients who have these types of cardiovascular concerns. Ruud Dobber, head of AstraZeneca’s BioPharmaceuticals Business Unit said the approval is “promising news” for the 30 million people in the United States who have type 2 diabetes. Dobber pointed out that heart failure is one of the earliest cardiovascular complications for these patients, ahead of heart attack or stroke.

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“Farxiga now offers the opportunity for physicians to act sooner and reduce the risk of hospitalization for heart failure,” Dobber said in a statement.

Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School and co-principal investigator of the DECLARE-TIMI 58 CV outcomes trial, said the clinical data collected from that study could help change the way physicians approach diabetes management. Wiviott said it can go “beyond a singular focus on glucose control to help address the risk of heart failure in a diverse population of patients.”

Farxiga won a similar approval in the European Union in August. A decision for this indication is expected in China in the first half of 2020.

Farxiga could pick up another regulatory win in the coming months. The FDA awarded Farxiga Fast Track designation as a treatment to reduce the risk of cardiovascular death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF). That designation was based on the results of the Phase III DAPA-HF and DELIVER trial that showed how the drug decreased the risk of heart failure. Approximately 40% of patients who participated in the trial had type 2 diabetes, a condition common among heart failure patients.

Additionally, Farxiga won Fast Track Designation in August as a treatment for patients with chronic kidney disease (CKD). When the designation was announced two months ago it was to delay the progression of renal failure and prevent cardiovascular (CV) and renal death in patients with CKD, the company said. The designation was assigned to CKD patients with and without type-2 diabetes.

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