Chasing rivals from AstraZeneca and Eli Lilly/Boehringer Ingelheim, Johnson & Johnson's Invokana is vying for a piece of the lucrative heart failure market.
J&J's Type 2 diabetes med helped improve patients' heart failure symptoms regardless of whether they had diabetes, phase 3 data presented at the American Heart Association's virtual Scientific Sessions 2021 showed.
With positive late-stage data in hand, Invokana could become the latest sodium-glucose co-transporter 2 (SGLT2) inhibitor to make the jump from Type 2 diabetes to heart failure, following in the footsteps of AstraZeneca's Farxiga and Eli Lilly and Boehringer Ingelheim's Jardiance.
Patients on Invokana reported "significantly greater improvement" in their heart failure symptoms versus placebo, investigators said. Benefits were seen within two weeks and lasted throughout the entire three-month trial period.
Improvements were observed in both heart failure patients with preserved ejection fraction (HFpEF), when the lower left portion of the heart doesn't fill with blood properly, as well as those with reduced ejection fraction (rEF), when the same section of the heart fails to pump blood properly.
The 476-patient study enrolled 285 patients with HFpEF, while the rest had HFrEF. A total of 133 patients had Type 2 diabetes. Researchers looked at patients' symptom reports at two, four, six and 12 weeks. The team ran the trial virtually because of the pandemic.
Patients self-reported their symptoms on smartphones using the Kansas City Cardiomyopathy Questionnaire, which measures patients' perception of their health. The descriptions of their symptoms are converted into a Total Symptom Score that ranges from zero, indicating most severe, to 100, which suggests they've had no symptoms for the past two weeks.
“Demonstrating the success of a decentralized clinical trial opens opportunities for applying this approach to the testing of other cardiovascular therapies that focus on health status," John Spertus, M.D., lead author of the study, said in a statement.
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If approved in heart failure, Invokana would be jockeying for space alongside diabetes rivals Farxiga and Jardiance. AZ's Farxiga won its green light in HFrEF in 2020, while Lilly and Boehringer's Jardiance scored a nod in the same indication in August.
Meanwhile, Invokana was the first-ever FDA approved SGLT2 inhibitor. It hit the scene in Type 2 diabetes way back in 2013 and snared $795 million in global sales last year.