A boxed warning for increased risk of leg and foot amputations will be added to the label of Johnson & Johnson’s (J&J’s) Type 2 Diabetes (T2D) drug, Invokana (canagliflozin).

This adds to the growing list of drawbacks in patients taking sodium-glucose cotransporter-2 inhibitors (SGLT-2Is), the newest T2D drug class, including reported cases of dehydration and ketoacidosis.

The drug class is unique as SGLT-2Is lower blood glucose levels in an insulin-independent manner, and harbour numerous non-glycemic advantages such as weight loss and a reduction in systolic blood pressure. Specifically, the inhibition of sodium-glucose cotransporter-2 (SGLT-2) hinders glucose reabsorption by the kidney.

SGLT-2Is were first launched in 2012, and include AstraZeneca’s Forxiga (dapagliflozin), J&J’s Invokana, and Eli Lilly / Boehringer Ingelheim’s Jardiance (empagliflozin). Currently, Jardiance has a distinct advantage in the SGLTI space as a result of positive outcomes from the EMPA-REG OUTCOME clinical trial, which showed that the drug successfully decreased the risk of heart attacks, strokes, and cardiovascular-related death in T2D patients.

The FDA has recently concluded that Invokana requires a boxed warning for its increased risk of leg and foot amputations. The decision comes after the regulatory body reviewed data from two clinical trials involving Invokana treatment, CANVAS and CANVAS-R. Findings from these studies revealed that patients were approximately twice as likely to get a leg or foot amputation when taking Invokana compared to patients on placebo.

As such, GlobalData believes that a likely scenario to emerge from these recent events would be Forxiga and Jardiance stealing significant patient share from Invokana in the US.

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By GlobalData

The European Medicines Agency (EMA) has also recognised the increased risk for lower limb amputations in patients on SGLT-2Is, but has expanded its warning to encompass all drugs belonging to the class: Invokana, Forxiga, and Jardiance.

Despite concerns associated with SGLT-2Is, key opinion leaders (KOLs) interviewed by GlobalData continue to advocate for the use of SGLT-2Is, as they are largely successful in treating T2D patients who are unable to adequately control their glycated hemoglobin (A1c) levels.

Related Reports

GlobalData (2016). PharmaPoint: Type 2 Diabetes – Global Drug Forecast and Market Analysis to 2025, May 2016, GDHC128PIDR.