AstraZeneca plans to provide a new treatment option for chronic kidney disease patients after recently expanding the indication for Forxiga, initially developed as type-2 diabetes treatment, from regulators, the company said Monday.
Some members of the Korean Society of Nephrology (KSN) also supported the company’s plan at a news conference.
"Forxiga, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, is no longer only a diabetes drug," Professor Choi Bum-soon of the Department of Nephrology at Eunpyeong St. Mary's Hospital said. "Most nephrologists will recognize the drug as a basic therapy that has a good protective effect on kidney function with options to use the treatment in combination with other drugs."
Other KSN members also said the expanded indication of SGLT2 inhibitors is meaningful, as there has been no clear way to protect the kidneys regardless of the presence or absence of diabetes other than management through angiotensin-converting enzyme (ACE) inhibitors or Angiotensin receptor blocker (ARB).
"Until now, there were not many options for drugs to help patients keep their kidney function from worsening," Professor Koh Kang-ji at Korea University Kuro hospital said. "Although renin-angiotensin-aldosterone system (RAAS) blockers are effective, the study is 20 years old, and there has been no new drug since then."
Therefore, neurosurgeons welcome the appearance of Forxiga. Moreover, since it effectively reduces intraglomerular pressure through a mechanism of action different from RAAS blockers, doctors can now use the two drugs interchangeably, Koh added.
The Ministry of Food and Drug Safety based the approval of expanded indication for Forxiga based on the company's DAPA-CKD study. The research confirmed the therapeutic effect and safety of Forxiga when administered in combination with standard therapy once a day in chronic kidney disease patients with increased urinary albumin excretion levels, regardless of whether they had type 2 diabetes.
In the study, Forxiga significantly reduced the risk of death from end-stage renal failure, renal disease, or cardiovascular disease by 39 percent or more, and a 50 percent or more decrease in the estimated glomerular filtration rate (eGFR), the primary composite endpoint, compared to placebo.
Professor Choi said that based on the clinical effect in the field, Forxiga’s emergence as a CKD treatment is very significant.
While agreeing to the need to expand the potential of SLGT-2 inhibitors with the expanded indication of Forxiga, the experts said that it is premature to expand it to the entire SGLT-2 inhibitor class.
"It seems to be too early to talk about the series effect with no results other than Forxiga yet," Professor Choi said. "Since each drug has different side effects and effects, we hope that other drugs will prove their effectiveness in the kidneys in the future."
KSN President Yang Chul-woo, a professor at St. Mary's Seoul Hospital, also said, "We expect Forxiga to lead the market as it was the first to elucidate the mechanism of action in the kidney."
In that respect, the association believes that Forxiga will play the role of a leader in the field, Yang added.
These nephrology doctors did not hide their excitement of the new possibility of Forxiga but noted that it would be difficult to prescribe Forxiga alone to chronic kidney disease patients for now.
"However, one of the characteristics of SGLT2 inhibitors is that they are easy to combine with other drugs, which is expected to compensate for the shortcomings of the drug," Professor Choi said. "I think Forxiga will become a basic drug used with other drugs rather than being used as a monotherapy."