Johnson & Johnson Announces Positive Phase 3 Results for Invokana in Heart Failure, Aiming to Compete with Farxiga and Jardiance

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Recently, phase 3 data released at the American Heart Association (AHA) 2021 Virtual Scientific Sessions showed that Johnson & Johnson's type 2 diabetes drug Invokana (canagliflozin) helped improve heart failure symptoms in patients, regardless of whether they had diabetes.

These positive data are expected to make Invokana the latest sodium-glucose co-transporter 2 (SGLT2) inhibitor, following AstraZeneca's Farxiga (dapagliflozin) and Boehringer Ingelheim/Lilly's Jardiance (empagliflozin), achieving a leap from treating type 2 diabetes to treating heart failure.

Researchers said that, compared with placebo, heart failure symptoms in patients taking Invokana showed "significant improvement." The efficacy was observed within 2 weeks of taking the medication and persisted throughout the 3-month trial period. Additionally, improvements were seen in both heart failure with preserved ejection fraction (HFpEF) and heart failure with reduced ejection fraction (HFrEF) patients.

This trial enrolled a total of 476 patients, including 285 HFpEF patients and 191 HFrEF patients. Among them, 133 patients also had type 2 diabetes. Researchers observed the patients' symptom reports at 2 weeks, 4 weeks, 6 weeks, and 12 weeks. Patients self-reported their symptoms using the Kansas City Cardiomyopathy Questionnaire (KCCQ) on a smartphone, which measures the patient’s perception of their own health. Descriptions of symptoms were converted into a total symptom score, ranging from 0 (most severe) to 100 (no symptoms in the past two weeks).

Due to the COVID-19 pandemic, the research team actually conducted a virtual clinical trial (also known as a "decentralized" or "distributed" clinical trial). The researchers stated that the success of this virtual clinical trial provides an opportunity to apply this method to other cardiovascular treatment trials focused on health conditions.

If approved for the heart failure indication, Invokana will compete with its counterparts Farxiga and Jardiance for market share. In May 2020, Farxiga received regulatory approval from the U.S. FDA for the treatment of HFrEF, while Jardiance also gained approval for the same indication in August this year.

Invokana is the first SGLT2 inhibitor approved by the U.S. FDA. The drug was launched in 2013 for the treatment of type 2 diabetes and achieved global sales of $795 million in 2020.

Source: AHA: J&J's Invokana Competes with AZ's Farxiga and Lilly's Jardiance in Phase 3 Heart Failure Trial