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 Monday approved Invokana to treat diabetic kidney disease and reduce the risk of hospitalization for heart failure in patients with type 2 diabetes patients and diabetic kidney disease. 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.
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.
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.
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.