Janssen has announced results from a new analysis of its Phase 3 CREDENCE, which demonstrated that Invokana (canagliflozin), its flagship sodium-glucose transport-2 inhibitor (SGLT-2I), was able to consistently reduce the risk of renal and cardiovascular (CV) events in patients with varying levels of kidney function.
Invokana has become the first anti-diabetic drug in almost 20 years indicated to slow the progression of diabetic kidney disease (DKD), and will give Janssen a competitive edge among other marketed SGLT-2Is.
Significantly improved creatinine clearance was observed in patients with advanced renal insufficiency—determined by an estimated glomerular filtration rate (eGFR) of less than 60ml/min/1.73m2—building on the positive primary results observed for treating DKD in the Phase 3 CREDENCE study. The absolute benefit for slowing the progression of kidney disease was greater in patients who already had renal insufficiency, as they were already at a substantially higher risk. No change was observed in the safety profile as eGFR decreased, providing increased confidence for physicians to prescribe Invokana across a broad range of eGFR levels. Invokana was also consistently able to lower the risk of CV and renal events in patients across all eGFR subgroups.
FDA grants approval to extend label
In September, the FDA granted approval to extend Invokana’s label to treat patients with DKD, and reduce the risk of hospitalization for heart failure (HF) in patients with type 2 diabetes (T2D) and DKD. Invokana is the first SGLT-2I to achieve these approvals and arrives at a time when there is increased awareness among physicians that cardio-renal metabolic diseases secondary to T2D are becoming more prevalent and more challenging to treat.
The FDA approval, and subsequent Phase III results analysis, cement Invokana’s dominant presence in the SGLT-2I space. It also addresses the concerns of many key opinion leaders (KOLs) interviewed by GlobalData around the need for novel T2D drugs that address the CV and renal comorbidities associated with T2D.