J&J's Invokana shines in PhII Type 1 diabetes study--but raises the risk of serious side effects, too


NEW ORLEANS--Johnson & Johnson’s Invokana is already coming up big for the company as a treatment for Type 2 diabetes. And the pharma giant recently got some encouraging signs that it may one day do the same in Type 1 diabetes, too.

In a Phase II study of Type 1 patients, Invokana--delivered alongside insulin--beat out a placebo-insulin combo at lowering both mean glucose levels and glycemic variability--and increased the amount of time patients spent within their target glucose ranges, J&J’s Janssen unit announced at the American Diabetes Association’s annual meeting.

“Less swings, less variability, more time in target range--these are all very good things,” Jim List, Janssen’s global head of cardiovascular and metabolism, told FiercePharma.

But the data wasn’t all quite as sunny. Invokana also upped the rate of serious adverse events related to ketoacidosis, a serious condition that can lead to coma or death.

Still, the results are encouraging for Janssen. Type 1 diabetes has been a thorn in the side of drugmakers, in part because “there have not been a great number of targets for intervening in the disease,” according to List.

“Clearly, there’s an effect going on and we’re very actively exploring all the possibilities of what we could do from here,” he said.

Meanwhile, Invokana has been helping fuel Street-beating sales for J&J. In Q1, it posted $325 million in worldwide sales--a 17% increase over the year-ago period--and that performance helped make up for floundering hep C med Olysio.

It does have a pair of serious SGLT2 rivals in Eli Lilly and Boehringer Ingelheim’s Jardiance, and AstraZeneca’s Farxiga, though; Jardiance, in particular, has been gathering momentum since last year becoming the first diabetes treatment to show it could cut down the combined risk of heart attack, stroke and cardiovascular death. And both of the New Jersey pharma giant’s competitors are hard at work, testing their contenders in Type 1 diabetes, too.

- read the release

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