Drug Approval | December 06, 2023
Zydus receives final approval from the USFDA for Ivabradine Tablets
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
Ivabradine Tablets, 5 mg and 7.5 mg had annual sales of USD 136.5 mn in the United States
The approval allows treatment of heart failure patients irrespective of the ejection fraction based on new trial DELIVER conducted by AstraZeneca
Results from the DELIVER and DAPA-HF Phase III trials demonstrate Dapagliflozin’ efficacy in heart failure regardless of ejection fraction
Approval based on groundbreaking Phase 3 EXPLORER-HCM trial demonstrating benefit in patients receiving Camzyos versus placebo
Ivabradine Tablets, 5 mg and 7.5 mg have an estimated market size of US $ 102 million for twelve months ending December 2021 according to IQVIA
The breakthrough approval expands the existing indication of Jardiance to include adults with heart failure with preserved ejection fraction (HFpEF), an underserved patient population that previously had no approved therapies in Europe
New treatment options are critical, as approximately half of all people with heart failure die within five years of diagnosis. Heart failure accounts for more than one million hospitalisations a year in the US
Subscribe To Our Newsletter & Stay Updated
