The Italian Medicines Agency (AIFA) has approved the reimbursement of empagliflozin, a reversible and selective inhibitor of sodium-glucose cotransporter type 2 (SGLT2), for the treatment of chronic kidney disease (CKD) in adult patients. This was announced in a note by Boehringer Ingelheim and Eli-Lilly, recalling that the information is reported in the Official Journal number 188 of 12 August 2024
The indication of empagliflozin in chronic kidney disease is based on the results of the phase III Empa-Kidney clinical study, and contributes to addressing an important unmet need in terms of efficacy in slowing the deterioration of renal function. The study, the largest ever conducted with a SGLT2 inhibitor, evaluated the efficacy and safety of the drug in over 6,600 patients with CKD, in a wide range of glomerular filtration rate (eGFR) values and with no or varying degrees of albuminuria, also including patients completely excluded or underrepresented in previous pivotal studies on CKD, thus reflecting the real care context. The results demonstrate that, in addition to standard of care, empagliflozin is effective in slowing disease progression or death from cardiovascular causes, with a relative risk reduction of 28% compared to placebo, regardless of the presence of diabetes, GFR levels (up to 20 mL/min) and the presence and extent of albuminuria at baseline. In addition, the drug significantly reduced the number of hospitalizations for any cause, with a relative risk reduction of 14% compared to placebo.
The updates of the international guidelines ‘Kdigo 2024 Clinical Practice Guideline’ of the world organization ‘Kidney Disease: Improving Global Outcomes’, for chronic kidney disease, widely recognize this evidence and recommend using therapy with an Sglt2 inhibitor as a first-line treatment for MRC. Empagliflozin therefore emerges as a valid therapeutic opportunity capable of improving the management of patients with chronic kidney disease who are poorly controlled with the current standard of care.
“The approval – says Luca De Nicola, professor of Nephrology at the University of Campania Luigi Vanvitelli, Naples – represents a huge step forward in the treatment of chronic kidney disease, a complex clinical condition with a progressive course and negative prognosis, characterized by a continuous evolution towards the most advanced stages, and which requires significant assistance and significant economic costs. Empagliflozin has shown that it is able to significantly slow the progressive evolution of renal and cardiovascular damage in a large population of patients affected by MRC, with and without diabetes, including patients with albuminuria of various degrees, even absent or low grade. However, it is necessary to underline – he adds – the importance of an early diagnosis of MRC, achievable through actions aimed at intercepting the disease in its initial stages, especially in subjects at high risk of developing it, such as patients with diabetes, hypertension, heart disease and obesity”.
Early diagnosis is, in fact, a crucial element in the treatment of the disease because the almost total absence of specific symptoms in the initial stages of the disease carries the risk of late recognition. Chronic kidney disease is a condition of altered kidney function, characterized by the presence of damage or decrease in kidney function, which persists for more than 3 months. It is a clinical condition with a progressive course and negative prognosis, which estimates a prevalence in Italy of 7-10% of the adult population, or approximately 3.5-5.0 million patients.
The approval just obtained for empagliflozin in the MRC follows that for the control of type 2 diabetes mellitus and for the treatment of heart failure (with preserved and reduced ejection fraction). “This approval – observes Elias Khalil, president and CEO of Lilly’s Italy Hub – is the confirmation of our commitment to bring innovative therapeutic solutions that can respond to the great unmet health needs not only in the therapeutic areas in which we are traditionally engaged as Lilly, but also in the broader panorama of metabolic diseases and their numerous interconnections. We are happy to be able to make this important therapeutic solution available to people suffering from chronic kidney disease in Italy”. The reimbursement obtained from Aifa “represents a step forward in the management of such a complex and insidious disease – underlines Morena Sangiovanni, president of the Boehringer Ingelheim Italia group – and demonstrates, once again, our commitment to finding solutions to address cardio-renal-metabolic diseases. Our research is increasingly oriented towards an approach based on the recognition and management of the interconnections existing between chronic pathologies, which we believe to be a turning point for the health of patients and in terms of sustainability – he concludes – for the national health system”.
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