EMEA May Revise Guidelines on Biomarkers for Heart Drugs

The European Medicines Agency (EMEA) is considering revising its guidelines on the use of surrogate biomarkers for heart drugs — a move that could potentially affect companies producing drugs to treat hypertension or lower lipid levels. The biomarkers, which measure the drugs’ effects on lipid levels in the blood and on blood pressure, are useful in clinical trials of new treatments — but may not provide enough information for a sound risk-benefit assessment, the EMEA’s Committee for Medicinal Products for Human Use says in a draft concept paper posted online recently. Comments are due Oct. 30.
International Pharmaceutical Regulatory Monitor