Brief

J&J's Invokana lowers CV risk, but by enough to compete?

Dive Brief:

  • Newly published results from a large-scale clinical study are underscoring the positive effects Johnson & Johnson's diabetes drug has on heart health, but underscore that it wasn't as successful in reducing risk as a competitor from Eli Lilly & Co. 
  • Invokana (canagliflozin), an approved medication for type 2 diabetes, led to a 14% risk reduction in the Phase 3 CANVAS study's composite primary endpoint — comprised of nonfatal myocardial infarction (MI), cardiovascular (CV) death and nonfatal stroke. Respectively, the treatment lowered the risk of patients experiencing those events by 15%, 13% and 10% in each of those categories.
  • A secondary endpoint of CANVAS and the primary endpoint of the separate, Phase 4 CANVAS-R investigation was the progression renal issues, particularly the presence of a protein called albumin in patients' urine, which could be a sign of liver disease. Invokana held off that progression, and lowered the risk of a composite of other renal outcomes, including death and replacement therapy, by 40%, according to a Monday statement.

Dive Insight:

While Invokana's performance across the CANVAS program was good, the drug still faces steep competition from other SGLT-2 inhibitors. EvercoreISI analyst Umer Raffat highlighted in a June 12 note that the drug's CV death data showed a hazard ratio of .87, well above the .62 Eli Lilly and Boehringer Ingelheim's Jardiance (empagliflozin) demonstrated in the big pharmas' own EMPA-REG cardiovascular outcomes study.

What's more, EMPA-REG investigators found that Jardiance slashed the risk of cardiovascular events by 14% and CV death by 38%. The new Invokana data, therefore, helps reaffirm the ability of the SGLT-2 class to treat diabetes and keep adverse heart conditions at bay, but doesn't necessarily give Johnson & Johnson's drug a leg up on rival pharmas.

"Lilly had said that the worst-case outcome going into Johnson & Johnson's CANVAS data would have been if the trial was negative … and best-case outcome would have been if CANVAS is positive, but not as positive as Lilly's EMPA-REG," Raffat said.

"It seems that CANVAS outcome is the best-case for [Lilly]."

SGLT-2 inhibitors are one of the more promising classes popping up in diabetes, given their promise in preventing cardiovascular problems. In addition to Invokana and Jardiance, AstraZeneca has its marketed drug Farxiga (dapagliflozin) and Merck and Pfizer have ertugliflozin, which just scored positive results in late-stage studies but is not yet approved.

The class has also been profitable. Johnson & Johnson reported $284 million in sales for Invokana, though that was a 13% decrease from the same period in 2016. Farxiga raked in $207 million during the first quarter for AstraZeneca, while Lilly reported $74 million in sales for Jardiance, almost double the year-prior period. Lilly gained approval from the Food and Drug Administration to add the cardiovascular benefits to the Jardiance label in December. While the expanded label has not significantly boosted Jardiance's share of the market, showcasing Invokana's cardiovascular benefits could help reinvigorate the franchise.

"Patients with diabetes are two to four times more likely to suffer from associated comorbidities, such as heart failure and kidney disease, and the CANVAS results demonstrate the potential of canagliflozin in reducing the risk for such conditions in high-risk type 2 diabetes patients," David Matthews, co-chair of the CANVAS Steering Committee, said in the June 12 statement.

Additional results from the study, which was published in the New England Journal of Medicine,found patients receiving Invokana had a 33% decline in risk of hospitalization for heart failure. The drug's safety profile was similar to previous findings, according to Johnson & Johnson. Last month,the FDA mandated the drug carry a black box warning for increased risk of foot and leg amputations.

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Filed Under: Clinical Trials