Results

J&J declares a historic success as Invokana comes through in PhIII chronic kidney disease trial

J&J has scored positive data from its Phase III chronic kidney disease study of the SGLT2 diabetes drug Invokana, possibly opening the door to a comeback after watching sales revenue dwindle in the face of a safety alert.

Researchers said after the market close $JNJ today that they had the snapshot of promising results they needed to call CREDENCE a success and end it early, “as the trial had achieved pre-specified criteria for the primary composite endpoint of end-stage kidney disease (time to dialysis or kidney transplantation), doubling of serum creatinine, and renal or cardiovascular (CV) death, when used in addition to standard of care.”

The actual data is being kept for scientific conference.

James List

“We are excited about the possibility of bringing forth Invokana (canagliflozin) as the first therapy to treat patients with chronic kidney disease and type 2 diabetes in more than 15 years,” says James List, J&J’s head of the Cardiovascular & Metabolism unit in a prepared statement.

J&J needed some good news on this front.

Invokana has carried a black box warning on it from last year flagging an increased risk of amputations. That set the stage for a series of analyst reports suggesting rival drugs at Eli Lilly/Boehringer and AstraZeneca would make gains on market share. But just weeks ago, J&J pushed back with new trial data demonstrating that the drug could cut the rate of heart failure hospitalizations without raising risks to patients.

J&J’s attempt to get risk reductions written into the label hit a setback earlier today, when the FDA delayed its decision. A 3-month extension pushes the PDUFA back to October.

In the meantime, sales have been shrinking as J&J’s competition ramps up. Invokana brought in $1.1 billion last year, down from $1.4 billion in 2016.

“Nearly half of all people with Type 2 diabetes will develop chronic kidney disease, causing a high risk of kidney failure and cardiovascular disease, and impacting their quality and length of life, even with the current best available care. This huge unmet need is why it was so important for us to initiate the landmark CREDENCE renal outcomes trial over four years ago,” said investigator Vlado Perkovic.


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