Lilly and Boehringer secure new PBS listing in kidney disease, competing with AstraZeneca’s in-class therapy

Pharma News: Eli Lilly and Boehringer Ingelheim’s SGLT2 inhibitor is set to face off AstraZeneca’s in-class rival for chronic kidney disease (CKD). Effective April 1st, Jardiance (empagliflozin) has been listed on the Pharmaceutical Benefits Scheme (PBS) for the treatment of patients with proteinuric CKD, regardless of whether they have type 2 diabetes.

According to Chris Forbes, CEO of Kidney Health Australia, one in six hospital admissions are attributed to chronic kidney disease, with a substantial economic toll of $9.9 billion annually.

“We know that to be successful in addressing kidney health, we need to work with the various comorbidities and treat the patient as a patient not as a disease,” commented Mr Forbes in a recent interview with Health Industry Hub.

The PBS listing of Jardiance follows closely on the heels of its Therapeutic Goods Administration (TGA) approval, expanding the pool of CKD patients eligible for SGLT-2 inhibitor therapy.

Professor Eugenia Pedagogos, Renal Physician at Western Health Victoria, hailed the PBS listing as a significant advancement in CKD care.

“Since the turn of the century, deaths associated with CKD have doubled and rates of kidney replacement therapy have risen by almost 150%. New first-line treatments like Jardiance are an essential component of CKD care, and the earlier the condition is diagnosed and treated the better,” Professor Pedagogos stated.

She added “CKD must also be managed holistically. Not only are we aiming to prevent declining kidney function and eventual kidney failure, but also the cardiovascular complications that go hand in hand with kidney disease. Treatment should protect both the kidneys and the heart.”

The efficacy and safety of Jardiance were underscored by findings from the EMPA-KIDNEY clinical trial, the largest trial of its kind for SGLT-2 inhibitors in CKD. Results showed a 28% reduction in the relative risk of kidney disease progression or cardiovascular death when Jardiance was added to standard care (P<0.001), alongside a 14% lower risk of hospitalisation for any cause compared to standard care alone (P=0.003).

While AstraZeneca’s Forxiga (dapagliflozin) was the first CKD therapy listed on the PBS in two decades, Lilly and Boehringer Ingelheim highlighted the unique nature of the EMPA-KIDNEY trial, which included CKD patients with diverse aetiologies and comorbidities; cardiovascular, kidney, or metabolic co-morbidities, including CKD patients without high levels of albuminuria.

Professor Pedagogos reassured general practitioners of the familiarity and efficacy of the therapy, saying “GPs are familiar with Jardiance and should feel confident when initiating first-line therapy for CKD, just as they do for type 2 diabetes and heart failure.”

Dirk Otto, General Manager of Boehringer Ingelheim Australia and New Zealand, emphasised the urgency of government investment in innovative medicines, particularly for diseases like CKD, which he termed a national health emergency.

“It is not only the leading cause of hospitalisation, but also a major driver of cardiovascular events in Australia,” Mr Otto said. He also noted that Jardiance remains available via private prescription for CKD patients not meeting the current PBS criteria.

“The best outcome for patients is to not be on dialysis, because every day not on dialysis is a good day,” Mr Forbes stated.

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