The European Medicines Agency (EMEA) is considering revising its guidelines on the use of surrogate biomarkers for heart drugs, which 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 said in its concept paper.
According to EMEA, “recent developments have raised additional doubts on the value of parameters such as HbA1c (anti-diabetics) or serum cholesterol (lipid-lowering agents) as predictors of clinical benefit for patients.” The agency also questioned whether a blood pressure decrease can quantitatively predict the clinical benefit of an antihypertensive agent disregarding other pharmacodynamic effects.
EMEA is proposing to revise its guidance in order to discuss the following aspects:
- Type and level of detail of the clinical and non-clinical information expected for a proper evaluation of the safety profile of a new medicinal product in relation to key organs and systems (cardiovascular safety, renal safety and hepatic safety).
- Discussion on whether the quantity and quality of information should be different depending on the mechanism of action of the medicinal product in question (known class toxicity, new class of drugs).
- Suggest a safety evaluation algorithm which, taking into account the totality of the data, may help to establish the need for outcome studies and the stage at which they will be required (pre- or post-licensing).
Comments are due Oct. 30.