Home health remedies J&J’s suffering Invokana scores new kidney disease nod. Can it turn sales...

J&J’s suffering Invokana scores new kidney disease nod. Can it turn sales around?

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Hit by a black-box warning for amputation risks, Johnson & Johnson’s SGLT2 diabetes drug Invokana has posted declining sales two years in a row as rivals grew. But now, the drugmaker has a label expansion its competitors can’t match. 

The FDA on Monday approved Invokana to treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in Type 2 diabetes patients. It’s now the only diabetes drug carrying the approval, Janssen’s global therapeutic head in cardiovascular and metabolism, James List, said in a statement

The approval comes after J&J in April reported that the drug—plus standard of care ACE inhibitors and angiotensin II receptor blockers—bested placebo at stalling kidney disease progression and fending off cardiovascular problems in patients with Type 2 diabetes and chronic kidney disease. J&J stopped the trial early last year and filed the data with the FDA in March. 

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Kidney disease is a common complication of Type 2 diabetes, and poor kidney function can trigger heart failure and other serious CV problems. Holding kidney disease at bay represents a “huge advance” for patients, List told FiercePharma at the time. J&J conducted the Credence study in 4,401 patients after earlier trials hinted at a kidney disease benefit for the med.  

RELATED: Invokana win in kidney patients could help J&J right the SGLT2 ship 

The new indication provides a boost for Invokana after the FDA in 2017 slapped the drug with a black-box warning for amputation risks. In 2016, the drug posted sales of $1.4 billion; the figure sank to $881 million last year. 

Meanwhile, as Invokana’s sales have slipped, its rivals have been gaining steam. Sales of AstraZeneca’s Farxiga grew 30% last year to $1.39 billion, AZ said. Boehringer Ingelheim reported sales of its Eli-Lilly-shared Jardiance that were up 45% to €1.46 billion. 

RELATED: Lilly, BI tout new Jardiance kidney analysis as rival J&J nears FDA nod 

J&J’s rival drugmakers have each touted study analyses showing kidney disease benefits for their respective drugs, but they haven’t completed dedicated renal outcomes trials. AstraZeneca in August scored an FDA Fast Track designation for Farxiga in chronic kidney disease.

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