R&D

Outracing 2 giant rivals, J&J touts promising PhIII Invokana data as a game-changer for kidney disease risks

In a race to expand market share against two top rivals in the diabetes field, J&J just scored one in the win column. And they’ll play it for all it’s worth in an attempt to revive flagging sales.

Researchers for the pharma giant spelled out a significant advantage for diabetics taking their SGLT2 standard bearer Invokana. In a Phase III study the drug scored a 30% reduction in the risk of a composite of ailments that many patients face: a progression to the doubling of serum creatinine, end-stage kidney disease and renal or cardiovascular death. Just looking at ESKD — a major fear among tens of millions of diabetics, 40% of whom will go on to develop kidney disease — there was a 32% reduction in risk.

James List

That data “could establish Invokana as the only medicine to safely reduce the risk of renal failure in this high-risk patient population when added to current standard of care,” said James List, J&J’s global head for cardio and metabolism.

Big deal? “It’s been almost 2 decades since there’s been a drug that slows progression in chronic kidney disease,” List tells me in a preview of the presentation. “It has the potential to change the way we treat chronic kidney disease.”

And this time they did it with no increased risk of amputations, providing J&J the safety profile they were looking for.

Whether Invokana in fact the only SGLT2 to score in this category has yet to be seen. The class offers a lot of similarities, though Invokana’s label has been handicapped by a risk for amputation that it doesn’t share with Jardiance from Eli Lilly and Boehringer Ingelheim and AstraZeneca’s Farxiga. Both rivals are in late-stage renal outcomes studies, so we’ll find out soon enough how well they fair against Invokana.

Not wanting to waste any time, J&J hustled their application to the FDA on March 27, hoping for a priority review that could cut down the turnaround to 6 months. In the meantime, Farxiga is expected to report out its results next fall, with Jardiance data arriving about 18 months later. That could give Invokana a head start, at least.

The drug needs all the help it can get. It’s revenue from Invokana fell last year to $881 million while AstraZeneca reported a big increase in Farxiga sales, which swelled to $1.39 billion. Jardiance revenue, meanwhile, grew 47% to $658 million in 2018.


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Research Scientist - Immunology
Recursion Pharmaceuticals Salt Lake City, UT
Director of Operations
Atlas Venture Cambridge, MA

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