Fresh analysis spotlights cardio benefit of J&J's Invokana in diabetes patients without history of CV disease
Invokana sales may be muted, but the diabetes drug is set to get some love after its maker J&J unveiled data at the American Diabetes Association meeting on Tuesday suggesting the medicine can confer a cardiovascular benefit in patients who do not have preexisting CV disease.
Back in April, J&J had reported that in the late-stage CREDENCE study, 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%. In March, the company submitted an application to expand Invokana’s label to reflect its impact on chronic kidney disease.
And yesterday, the company presented data from patients with CV risk factors but no history of it, along with patients who do (the secondary prevention group). Data showed that Invokana curtailed the risk of CV death, heart attack and stroke by 32% in the primary prevention group and 15% in the secondary prevention group.
Whether Invokana is special remains to be seen. Although the class of drugs is united by similarities, Invokana’s label is handicapped with a risk of amputation, unlike Jardiance from Eli Lilly and Farxiga from Boehringer Ingelheim and AstraZeneca. These drugs are also being evaluated in late-stage renal outcomes studies.
Invokana is in trouble — so the fresh analysis 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.
“Importantly, in this trial there was no imbalance seen in lower limb amputations with patients treated with Invokana, which could potentially allow for the product’s label to be amended and the Black Box Warning around lower limb amputations to be removed. Until this happens, however, we would expect other SGLT-2s such as Lilly’s Jardiance and Astra’s Farxiga to see greater benefit since they do not have this safety warning on the label and at least some of the physicians we spoke to at the meeting see this impact on kidney disease as a class effect. Lilly is running their own chronic kidney disease trial with Jardiance with data expected in 2022, as well as the two ongoing chronic heart failure studies that should have data in 2020 and 2021,” Credit Suisse’s Vamil Divan wrote in a note.