Amarin Applauds HealthyWomen’s Citizen’s Petition Urging FDA To Take Further Action On Fenofibrate Prescribing in Patients at Risk of Cardiovascular Event
“Despite the many safe, effective, and FDA-approved treatments available on the market with clinically proven reductions of CVD risk, patients are still being treated with fenofibrates off-label.
- “Despite the many safe, effective, and FDA-approved treatments available on the market with clinically proven reductions of CVD risk, patients are still being treated with fenofibrates off-label.
- This results in patients taking a drug proven to have no clinical benefit to reduce CVD risk,” said Nabil Abadir, M.D., Chief Medical Officer at Amarin.
- “This is a significant issue that is risking patient health and should be addressed quickly by the FDA.
- The petition also urges the FDA Commissioner to further clarify the position the agency previously took by removing the statin co-administration from fenofibrate labeling.