- Johnson & Johnson said Friday its diabetes drug Invokana will now carry a label in Europe that includes language describing its cardiovascular benefit, a key competitive factor in an increasingly contested market.
- The European Commission gave an OK permitting the product information for Invokana to reflect results from J&J's cardiovascular outcomes study CANVAS, which showed the SGLT-2 inhibitor reduced the risk of major adverse heart events compared to placebo.
- Data from CANVAS proved somewhat of a double-edged sword, however, as the results gave evidence that Invokana was associated with a roughly two-fold increase in the risk of lower limb amputations. The drug already carries warnings of that risk in both the U.S. and Europe.
Cardiovascular outcomes studies have become a key test for diabetes medicines, particularly those in the SGLT-2 and GLP-1 drug classes.
Heart-related complications are a common comorbidity of patients with Type 2 diabetes, making those medicines that can show a cardio-protective benefit as well as control blood sugar more competitive.
In 2015, Eli Lilly's EMPA-REG study of its SGLT-2 inhibitor Jardiance (empagliflozin) set the bar for rival drugs like Invokana (canaglifozin) and AstraZeneca's Farxiga (dapagliflozin).
Results from CANVAS showed that Invokana reduced the risk of a composite of major adverse heart events by 14% versus placebo. That was similar to EMPA-REG's topline result but fell short of the risk lowering on death by cardiovascular cause shown in Lilly's study.
Since then, Jardiance has steadily eroded Invokana's long-time position at the top of the SGLT-2 class. Data from Iqvia cited by Leerink, an investment firm, show that weekly total prescriptions in the U.S. for Jardiance overtook J&J's around the beginning of this year. Farxiga, while still third by the same measure, trails closely on Invokana's heels.
AstraZeneca expects results from its own outcomes study DECLARE in the second half of this year, with a regulatory application to follow next year.
Securing updates to Invokana's label to reflect CANVAS is therefore an important step for J&J. But, in the U.S., the Food and Drug Administration has extended its review of the company's application for another three months, until October.
In most European countries, J&J last year licensed to Mundipharma rights to distribute and sell Invokana.