AZ’ Farxiga shows CV benefit in diabetes patients

Trial data show that AstraZeneca’s Farxiga (dapagliflozin) cut the relative risk of major adverse cardiovascular events (MACE) by 16% compared to placebo in patients with type II diabetes who had a prior heart attack.

Also, in a second pre-specified sub-analysis of data from the DECLARE-TIMI 58 study, the SGLT2 inhibitor reduced the relative risk of hospitalisation for heart failure (hHF) in patients with the condition, regardless of their ejection fraction (EF) status, a measurement of the percentage of blood leaving the heart with each contraction, AZ said.

"We now have new evidence from DECLARE-TIMI 58 that shows Farxiga consistently reduced hospitalisation for heart failure across a broad range of patients with type II diabetes, regardless of their history of existing CV disease, including heart attack, or heart failure," noted Dr Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, a senior investigator with the Thrombolysis in Myocardial Infarction (TIMI) study group and co-principal investigator of the trial.

"These data build upon the existing evidence of the cardio-renal effects of Farxiga, with important new evidence on heart failure and MACE," added Elisabeth Björk, senior vice president, head of late Cardiovascular, Renal and Metabolism, R&D BioPharmaceuticals, at the drug giant.

"Heart failure is one of the most common early cardiovascular complications of type II diabetes. Despite advances in healthcare, it remains as life-threatening and prevalent as the combined incidence of the top-four most common forms of cancer. Therefore, more needs to be done for patients," she stressed.

The data were presented at the American College of Cardiology’s (ACC) 68th Annual Scientific Session, New Orleans, US, and were published in the journal Circulation.

Orphan status for IPF drug

Meanwhile, the US Food and Drug Administration (FDA) has granted Orphan Drug Designation for AZ’ experimental idiopathic pulmonary fibrosis (IPF) drug saracatinib.

Saracatinib is an inhibitor of src kinase which regulates broad cell functions including cell growth and cell differentiation.

The drug has completed Phase I development; Phase II trial have not yet commenced.

"Idiopathic pulmonary fibrosis has a significant impact on patients’ lives and new therapies are urgently needed," said Mene Pangalos, executive vice president, R&D BioPharmaceuticals.

"IPF is a recent addition to our respiratory research strategy and we are interested to see whether saracatinib could be a useful approach for the treatment of this intractable disease."

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