J&J's embattled Invokana gets a boost as FDA expands label
For Johnson & Johnson’s ailing diabetes drug Invokana, the expansion of its label could be the antidote that revives sales.
On Monday, the FDA expanded the drug’s label to slow the progression of diabetic nephropathy (DKD), as well as to reduce the risk of hospitalization for heart failure in patients with type II diabetes and DKD — an indication that no other type II diabetes medicine is approved for.
The approval is based on data from the late-stage CREDENCE study, in which the SGLT2 drug scored a 30% reduction in the risk of a composite of ailments: a progression to the doubling of serum creatinine, end-stage kidney disease, and renal or cardiovascular death. In terms of secondary endpoints, the drug was also found be heart-protective: lowering the risk of CV death and hospitalization for heart failure by 31%, as well as major adverse CV events by 20%.
Invokana, akin to Jardiance from Eli Lilly’s $LLY and Farxiga from Boehringer Ingelheim and AstraZeneca, belong to a class of diabetes drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors, which work by curbing the absorption of glucose via the kidneys so that surplus glucose is excreted through urination. Although the class of drugs is united by similarities, Invokana’s label is crippled with the risk of amputation, unlike Jardiance and Farxiga.
In CREDENCE, however, Invokana did not enhance the risk of amputations.
Invokana is in trouble — so the fresh approval is welcome. Last year, drug sales slipped to $881 million, while AstraZeneca posted a jump in Farxiga sales, which swelled to $1.39 billion. Jardiance revenue, meanwhile, catapulted 47% to $658 million in 2018. According to Cowen data, last week Jardiance’s market share was at 56%, Farxiga’s was at 23.7%, while Invokana’s was at 15.1%.
Lilly is running their own Jardiance chronic kidney disease trial with data expected in 2022, as well as the two ongoing chronic heart failure studies that should read-out in 2020 and 2021. AstraZeneca’s Farxiga has reported some positive pivotal data in kidney disease patients, and as of August received the FDA’s fast-track status for use in patients to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease.
In the United States, one in three type II diabetics also suffers from DKD — multiplying their risk of cardiovascular complications, dialysis, and kidney transplant, J&J said.