Alirocumab to prevent heart attack in USJuly 5, 2019
Alirocumab (Praluent) has been granted approval to reduce the risk of heart attack, stroke, and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease.
The US FDA approval is based on data from Odyssey Outcomes assessing the effect of adding Praluent to maximally tolerated statins on CV outcomes in 18,924 patients who had acute coronary syndrome (ACS) within a year of enrolling in the trial.
Alirocumab is approved in more than 60 countries worldwide, including the US, European Union (EU), Japan, Canada, Switzerland, Mexico and Brazil. In the US, the drug is approved to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization. Alirocumab is also approved as an adjunct to diet, alone or in combination with other lipid-lowering therapies, for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C.