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J&J's Invokana closes in on badly needed kidney disease nod with FDA 'priority' boost

When it comes to Invokana sales, Johnson & Johnson needs a way to stop the bleeding. And it just got one step closer to a new indication that could do just that.

The FDA granted the drug a priority review in patients with diabetes and chronic kidney disease (CKD), based on an outcomes trial showing Invokana could cut disease and death risks. The move sets the drug up for a speedy approval and a shot at a sales boost later this year.

If the agency approves the new use, J&J could market Invokana to cut the risk of end-stage kidney disease and kidney-related or cardiovascular death in patients with both Type 2 diabetes and CKD. That's a distinction its rivals don't now have, and one that could help counterbalance a safety warning that other SGLT2 drugs don't have, either.

Regulators based their decision on phase 3 data showing Invokana, combined with standard-of-care treatment, topped the standard of care alone at staving off kidney disease progression. The SGLT2 drug also slashed the risk of cardiovascular death and heart failure-related hospitalizations by 31%.

The data represent a “huge advance” for patients, Jim List, cardiovascular head at J&J’s Janssen, said at the time.

They also represent a chance for J&J to get a jump on its competitors, which are studying their own SGLT2 drugs in kidney disease. AstraZeneca in 2016 launched a Phase IIIb study of its Farxiga in CKD, while partners Boehringer Ingelheim and Eli Lilly in 2017 rolled out plans to start a similar outcomes study for their contender, Jardiance.

If approved, though, Invokana would be the first of the group—and the first diabetes med in general—to treat CKD in patients with Type 2 diabetes, J&J noted, and that distinction could result in some much-needed sales firepower.

The drug has been suffering in the diabetes arena thanks to a boxed warning detailing its increased risk of lower-limb amputations. A delay on its heart-helping approval—doled out on the back of positive CV outcomes data—didn't help its prospects.

Last year, Invokana sales sunk to $881 million from $1.4 billion back in 2016. And the damage has continued through early 2019, with Q1 sales of $154 million marking a 25% slide from the same period a year prior.

May 23, 2019


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