The Food and Drug Administration (FDA) has approved Astra AstraZeneca Philippines’ Dapagliflozin to treat heart failure among adult patients.
With the FDA’s approval, Dapagliflozin is the first and only drug under the sodium glucose transport protein 2 inhibitor (SGLT2i) class approved to treat heart failure in adult patients with reduced ejection fraction (pumapalyang puso), AstraZeneca Philippines said in statement.
The multinational pharmaceutical company noted that the Dapagliflozin, a medicine for diabetes, is the only SGLT2i proven to significantly prevent cardiovascular death and death due to other causes among patients with heart failure.
AstraZeneca Philippines Country President Lotis Ramin expressed AstraZeneca’s commitment to uplift the standard of care of Filipino patients by providing them with innovative and accessible treatment.
She welcomed the FDA’s approval of Dapagliflozin based on the landmark trial Dapagliflozin and Prevention of Adverse-outcomes in Heart Failure Trial (DAPA HF), describing it as a "testament of the company’s commitment in pushing what science can do to address unmet needs in healthcare.”
"The results from DAPA HF highlight the potential of a novel approach to greatly improve outcomes for patients with HFrEF by slowing disease progression and improving morbidity and mortality.”
She noted that DAPA HF is the first outcomes trial with an SGLT2 inhibitor investigating the treatment of Heart failure with reduced ejection fraction (HFrEF), with and without type-2 diabetes (T2D).
DAPA HF results revealed a reduction of 26 percent in the occurence of cardiovascular death, hospitalization for heart failure (hHF) and Urgent Hospital Visit for heart failure (HF) along with a 30 percent reduction in hHF. It also showed Dapagliflozin’s significant 18 percent reduction in cardiovascular death and 17 percent reduction on death due to other causes
"Dapagliflozin has the potential to become a long-awaited addition in the standard of care for this patient population,” Ramin said.
According to AstraZeneca, Dapagliflozin has offered an additional treatment option for patients suffering from the symptoms of heart failure and are at risk of dying given the high mortality rate of the disease.
"Safety findings in patients with and without type 2 diabetes were consistent with the well established safety profile of Dapagliflozin in previous studies. It is consistent regardless of age, gender, severity of heart failure, diabetes status and kidney function,” it said.
Dapagliflozin was well tolerated and adverse event rarely led to the discontinuation of treatment, it noted.
Dr. Orly Bugarin, president of the Philippine Heart Association also cheered at the decision of the FDA, saying that it bodes well in the Philippine situation.
"Despite advances in therapy with heart failure, mortality and morbidity remain high. This signifies that there is still an unmet need for an effective heart failure treatment which Dapagliflozin may address.”
Dr. May Donato-Tan, president of Heart Failure Society of the Philippines, also took note of the FDA’s approval of Dapagliflozin, saying that it "gives hope to heart failure Filipino patients.”
It "is a welcome strong addition in the field of heart failure because it allows heart failure patients to prevent hospitalizations and death from other cardiovascular causes.”
Initially, Dapagliflozin is approved in the country for glycemic control and for the prevention of new or worsening hospitalization for heart failure or cardiovascular death and nephropathy in adult patients with Type 2 Diabetes.
With the FDA’s approval, Dapagliflozin can now be used for the treatment of heart failure with reduced ejection fraction in adult patients.
However, AstraZeneca reminded that Dapagliflozin is a prescription medicine and patients should not self-medicate and should consult their physicians regarding their condition and treatment.