Philippine FDA approves new indication for diabetes drug

The AstraZeneca diabetes drug Dapagliflozin has been approved by the Philippine Food and Drug Administration (FDA) for the prevention of new or worsening heart failure or cardiovascular death in adult patients with type 2 diabetes.

Dapagliflozin is a first-in-class, oral medication that belongs to a class of drugs called SGLT2 inhibitors. Aside from its new indication, it is indicated as both monotherapy and as part of combination therapy to improve blood glucose control, with the additional benefits of weight loss and blood pressure reduction, as an adjunct to diet and exercise.

The FDA approval is based on the results of DECLARE-TIMI 58, the largest, broadest and longest SGLT2 inhibitor cardiovascular outcomes trial to date. The trial involved 17,160 type 2 diabetes patients, 60 percent of who have cardiovascular risk factors and 40 percent have established cardiovascular disease.

“The newly approved indication is a welcome development for local type 2 diabetes patients with multiple cardiovascular risk factors or established cardiovascular disease. By following the science to understand more clearly the underlying links between the heart, kidneys and pancreas, AstraZeneca is investing in a portfolio of medicines to protect organs and improve outcomes by slowing disease progression, reducing risks and tackling co-morbidities,” said Lotis Ramin, President, AstraZeneca Philippines.

“Dapagliflozin is the only type 2 diabetes treatment shown to reduce the risk of composite of cardiovascular death or hospitalization for heart failure in type 2 diabetes patients with multiple cardiovascular risks or established cardiovascular disease. Additionally, it has also been shown to reduce the risk of kidney events in these patient groups,” said Dr. Cyril Tolosa, Medical Affairs Director, AstraZeneca Philippines.

“There are over 3.7 million Filipinos with type 2 diabetes. Up to 50 percent of type 2 diabetes patients will develop heart failure and up to 40 percent will develop chronic kidney disease. Half of patients with heart failure will die in five years. With its new indication, Dapagliflozin will help protect these patients by helping them achieve optimal blood sugar control,” said Dr. Nemencio Nicodemus, Endocrinologist, Philippine General Hospital.

“Heart failure is an often forgotten first manifestation of type 2 diabetes-related complications and is more frequent than heart attack or stroke. Dapagliflozin can be an important part of the armamentarium in preventing or managing heart failure in our type 2 diabetes patients,” said Dr. Erlyn Demerre, Cardiologist, St. Luke’s Medical Center.

“Using Dapagliflozin early in type 2 diabetes to assist with HbA1c control may also help to prevent progression of renal disease in patients with and without established cardiovascular disease,” said Dr. Elizabeth Roasa, Nephrologist, University of Santo Tomas Hospital.

“The DECLARE–TIMI 58 trial showed that in a broad population of patients with type 2 diabetes, the use of Dapagliflozin resulted in a significantly lower rate of cardiovascular death or hospitalization for heart failure compared to placebo, with additional findings supporting a possible lower rate of adverse renal outcomes,” said Professor Subodh Verma, Cardiac Surgeon-Scientist, St. Michael’s Hospital Toronto Canada.

Optimal diabetes management is crucial during this time of pandemic. People with diabetes have a higher risk of experiencing serious complications from Covid-19. Patients with well-managed diabetes have lower risk of developing serious Covid-19 disease.

The safety and tolerability profile of Dapagliflozin is well-established and backed by a wealth of clinical experience, with over 2.5 million patients treated across more than 90 countries. Dapagliflozin is a prescription medicine. Patients should consult their physicians regarding their diabetes condition and their treatment.


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