Sales of Johnson & Johnson’s diabetes drug Invokana have suffered since the FDA put a warning in the box on the label describing the product’s amputation risks. But in a nutshell, the bureau now says this warning has been removed.
The FDA this week scrapped the warning in the box – which has praised the Invokana label since 2017 – after reviewing data from three clinical trials, it said in a memo for drug safety.
The reasoning was twofold: For one, while Invokana increased risks in trials, the FDA found at second glance that the risk was “lower than previously described,” especially when patients were “appropriately monitored,” it said.
And for two, it’s all about risk-taking, the agency said – and with more recent data showing that Invokana can help the heart and kidneys, the amputation risks outweigh the “significantly improved benefit” of the medicine.
That is not to say that the amputation threat does not appear on the Invokana label at all. It will still be described in the “Warnings and Precautions” section of the med’s prescriptive information, the FDA said.
J & J’s Janssen unit said for its part “pleased with the FDA’s recognition of the important benefits Invokana brings to people living with type 2 diabetes.”
“At Janssen, we have always had confidence in the overall safety profile of Invokana,” it said in a statement, adding that it believes “these changes to prescribing information appropriately communicate the safety and efficacy profile of this treatment to patients.”
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While the move represents a major obstacle on the road for Invokana, much has been done in recent years to drug sales. The product, which competes against Boehringer Ingelheim and Eli Lilly’s Jardiance and AstraZeneca’s Farxiga in the SGLT2 class, has seen revenue shrink by almost half since peaking since 2016.
That year – the last full year of sales for the warning in the boxes – Invokana tumbled up $ 1.41 billion, a counter that has slowly shrunk in recent years to reach just $ 735 million in 2019.
J&J, however, cannot necessarily blame the entire slide for the warning. In late 2016, rival Jardiance added its ability to reduce patients’ cardiovascular death risk to its label, as the first heart-assisting indication for the class and gave it an impetus over its competition.
Since then, Invokana has continued to win its own expansion of a few labels. In 2018, it included clearance to reduce the combined risk of heart attack, stroke or CV death in patients with high-risk Type 2 diabetes; it followed in 2019 with a continuation to reduce the risk of kidney disease, worse kidney function, CV death and hospitalization for heart failure in certain patients with type 2 diabetes and diabetic kidney disease.
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However, competition is still growing, with Farxiga from Jardiance and AstraZeneca – now the class’s sales leader – chasing their own kidney implants.
In March, the FDA Jardiance gave a rapid assessment as a treatment to reduce progression of kidney disease and cardiovascular death in patients with chronic kidney disease. And last month, Farxiga reached its primary endpoint of impaired kidney function, end-stage renal disease and cardiovascular death in a pivotal phase 3 trial for chronic kidney disease patients.
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