FDA warns of increased risk of leg, foot amputations with canagliflozin

FDA warns of increased risk of leg, foot amputations with canagliflozin

FDA warns of increased risk of leg, foot amputations with canagliflozin

Johnson & Johnson's type 2 diabetes medicine Invokana (canagliflozin) will now be required to carry a black box warning for an increased risk of foot and leg amputations, the Food and Drug Administration said Tuesday in a safety alert posted to its website. We are requiring new warnings, including our most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this risk.

Final results from two clinical trials showed that leg and foot amputations occurred about twice as often in patients treated with canagliflozin compared to patients treated with placebo, which is an inactive treatment. "Some patients had more than one amputation, some involving both limbs". In February, EMA noted the potential increased risk of lower limb amputation (mostly affecting the toes) in patients taking canagliflozin and other SGLT2 inhibitors, including dapagliflozin and empagliflozin for type 2 diabetes.

Leerink analyst Seamus Fernandez expects Lilly to benefit from an influx of Invokana patients transitioning to one of its diabetes meds, Jardiance.

Invokana, an SGLT2 inhibitor, was approved in the European Union in 2013 to lower blood glucose levels in people with type 2 diabetes. Canagliflozin lowers blood sugar by causing the kidneys to remove sugar from the body through the urine.

Now, though, "the increasingly differentiated labels and data to date suggest that ..."

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The warning comes after the agency reviewed data from two randomized, placebo controlled trials (CANVAS and CANVAS-R) that showed rates of lower-extremity amputations were doubled in the active drug groups, irrespective of dose.

J&J had been hoping the trials, dubbed Canvas and Canvas-R, would turn up results that would make physicians more inclined to prescribe the product, not less. Researchers examined benefits of Invokana on the kidneys. If left untreated, type 2 diabetes can lead to kidney damage, heart disease, and blindness.

Still, the entire SGLT2 needs to grow for Jardiance to meet or beat forecasts.

So far in 2017, Farxiga has seen a substantial boost in sales, which totaled $207 million over the first three months of the year. He forecasts the entire class growing to $4 billion in 2021 from $2.1 billion this year.

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