Philippine FDA approves new indication for AstraZeneca diabetes drug 

    Photo shows participants of the virtual media briefing making a FIGHT sign with their arms to signify their commitment to FIGHT the complications of type 2 diabetes and COVID-19 (from top left, clockwise): Dr. Elizabeth Roasa, Nephrologist, University of Santo Tomas Hospital; Dr. Erlyn Demerre, Cardiologist, St. Luke’s Medical Center; Dr. Cyril Tolosa, Medical Affairs Director, AstraZeneca Philippines; Professor Subodh Verma, Cardiac Surgeon-Scientist, St. Michael’s Hospital Toronto Canada; Dr. Nemencio Nicodemus, Endocrinologist, PGH; and Dr. Alberto Pamplona, Medical Affairs Manager, AstraZeneca Philippines.

    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 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 Ms. 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.

    “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.

    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.