FDA okays pill for chronic kidney disease

FILE PHOTO: Facade of FDA office.

MANILA, Philippines — An oral drug originally developed for diabetes was recently approved by the local Food and Drug Administration (FDA) for the treatment of chronic kidney disease (CKD) in adults.

Oral pill dapagliflozin was approved for the treatment of CKD on February 2022, according to Dr. Cyril Tolosa, head of medical affairs of AstraZeneca Philippines, the sole producer of the prescription tablet.

In a press briefing in celebration of World Kidney Day, nephrologist Dr. Rey Isidto said dapagliflozin is the only maintenance medication for CKD currently available in the country.

Isidto said, however, that dapagliflozin should be taken with a prescription from a doctor.

He cited the findings of a clinical study published in 2020 that showed that dapagliflozin reduced the progression of CKD and halved the risk of death due to renal causes.

Isidto was the Philippine representative for principal investigators of the study.

Dapa-CKD study

The study, titled “Dapagliflozin on Renal Outcomes and Cardiovascular Mortality in Patients with CKD” (Dapa-CKD), was participated in by 4,304 CKD patients from 21 countries, 115 of whom were Filipinos. It was conducted for two years starting 2018.

“This drug was actually given as an add-on. So the patients already have their own standard of care, and patients are already receiving other medications,” Isidto said.

Dapagliflozin was first approved by the local FDA as a diabetes medication in 2015. Its mode of action, Isidto said, is it releases excess glucose in the urine, resulting in the reduction of excess sugar in the blood.

“The Dapa-CKD study is so significant that it caused a paradigm shift in the management of CKD. No other medications can be offered to patients with CKD, until now, other than our standard of care,” Isidto said.

Increased risk

Meanwhile, in a separate online briefing, nephrologist Dr. Carlo Trinidad reminded that kidneys are not spared after COVID-19 infection as the coronavirus disease affects blood vessels.

According to Trinidad, this does not mean that COVID-19 survivors would automatically develop chronic kidney disease, but rather puts them at an “increased risk” to develop severe or acute kidney problems.

“They are at risk because COVID-19 affects our blood vessels, the ones that carry blood from the heart over to our organs. Especially the kidneys, they are very hungry for blood,” Trinidad said.

About 2.3 million Filipinos have CKD, equivalent to one Filipino developing the disease every hour, according to government data as of 2016.

From January to November last year, 2,644 people died of kidney-related diseases, according to data from the Philippine Statistics Authority.

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