The UK National Institute for Health and Care Excellence (NICE) recently announced approval for AstraZeneca’s sodium glucose co-transporter 2 (SGLT2) inhibitor Forxiga (dapagliflozin) for chronic kidney disease (CKD). GlobalData believes that NICE’s approval for use of Forxiga signifies the drug’s major advantage over existing treatments and in targeting reduced glomerular filtration rate (GFR) and all-cause death. As CKD’s pathophysiology is most often tracked through an analysis of GFR, Forxiga’s approval is significant, as it can potentially reduce pressure in the glomeruli of the kidney, thus protecting them from damage.
Forxiga will be offered as part of the best current treatment, used alongside angiotensin-converting enzymes (ACE) inhibitors and angiotensin receptor blockers (ARBs) for the management of CKD. It will not, however, be a treatment option for transplant patients. SGLT2 inhibitors are not expected to be in direct competition with other classes of drugs, as they will be used in combination with other drugs for the management of CKD, making the market share of other drugs unaffected by the increased presence of alternative agents.
Key opinion leaders (KOLs) interviewed by GlobalData have emphasised that there is a desperate need for studies that investigate morbidity, comorbidity and hospitalisation endpoints in patients with CKD stages II-IV. According to data from the Phase III DAPA-CKD trial, Forxiga, in combination with standard of care, specifically ACE inhibitors and ARBs, lowered the composite risk of worsening renal function by 39% compared to placebo (risk lowered by 5.3%, p<0.0001). In addition, there was a significant (31%) reduction in risk of death from any cause compared to placebo, and Forxiga’s safety and tolerability data were in line with its existing safety profile. This positive trial data supported Forxiga’s priority review, since it offers significant advances over available options and demonstrated better efficacy, thus preventing the risk of cardiovascular and renal death.
According to physicians surveyed by GlobalData, guidelines followed by nephrologists in the UK are those published by NICE and the KDIGO clinical practice guidelines. Present guidance suggests dapagliflozin will be made available in patients with broad kidney damage and protein leaking into their urine. This consist of patients with an estimated GFR of 25–75mL/min/1.73m².
Guidelines updates regarding the use of SGLT2 inhibitors for CKD are expected to be published in the coming weeks. KOLs have highlighted that while side effects are favourable, nephrologists are unfamiliar with this class of drugs and will require guidance on dosage and monitoring instructions.