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Johnson & Johnson releases Phase III results of hypoglycemic drug Invokana
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Johnson & Johnson releases Phase III clinical results of hypoglycemic drug Invokana, which is expected to catch up with Farxiga/Jardiance,
Recently, Phase 3 data released at the 2021 Virtual Science Conference of the American Heart Association (AHA) showed that Johnson & Johnson’s type 2 diabetes drug Invokana (canagliflozin) has helped improve the symptoms of heart failure in patients, regardless of whether they have diabetes.
These positive data are expected to make Invokana the newest sodium-glucose cotransporter 2 (SGLT2) inhibitor after AstraZeneca’s Farxiga (Dapagliflozin), Boehringer Ingelheim/Lilly Jardiance (Enpagliflozin), Achieve a leap from the treatment of type 2 diabetes to the treatment of heart failure.
According to the researchers, patients taking Invokana showed “significant improvement” in heart failure symptoms compared to placebo. The effect was seen within 2 weeks of taking the drug and continued throughout the 3-month trial period. In addition, both heart failure patients with preserved ejection fraction (HFpEF) and heart failure patients with reduced ejection fraction (HFrEF) improved.
A total of 476 patients were enrolled in this trial, including 285 patients with HFpEF and 191 patients with HFrEF. A total of 133 patients have type 2 diabetes at the same time. The researchers observed the patient’s symptom reports at 2, 4, 6 and 12 weeks. Patients self-report symptoms on their smartphones using the Kansas City Cardiomyopathy Questionnaire (KCCQ), which measures the patient’s perception of self-health. The description of the symptoms is converted into a total symptom score, ranging from 0 (most severe) to 100 (no symptoms in the past 2 weeks).
Due to the COVID-19 pandemic, the research team actually conducted virtual clinical trials (also known as “decentralized” or “decentralized” clinical trials). The researchers said that the success of this virtual clinical trial provides an opportunity to apply this method to other cardiovascular treatment trials that focus on health conditions.
If approved in the heart failure indication, Invokana will keep pace with similar products Farxiga and Jardiance to compete for market share. In May 2020, Farxiga received regulatory approval from the US FDA for the treatment of HFrEF, and Jardiance received approval for the same indication in August this year.
Invokana is the first SGLT2 inhibitor approved by the US FDA. The drug was launched in 2013 for the treatment of type 2 diabetes, with global sales of US$795 million in 2020.
AHA: J&J’s Invokana chases AZ’s Farxiga and Lilly’s Jardiance with phase 3 heart failure win
Johnson & Johnson releases Phase III clinical results of hypoglycemic drug Invokana
(source:internet, reference only)