The European Medical Evaluation Agency (EMEA) recommended that Servier’s drug Coversyl should have its indication extended to include the treatment of high blood pressure in patients with stable coronary artery disease. The FDA has now also approved a label extension for the drug for a similar indication in the US.
The EMEA’s green light for the new indication of Coversyl was based on results from a trial involving 12,218 patients with stable coronary artery disease which showed that Coversyl significantly cuts the risk of cardiovascular mortality and non-fatal heart attacks by 20% compared to placebo.
Servier’s pipeline drug Procoralan, the first pure heart rate-lowering agent, also received an EMEA positive opinion, for the treatment of chronic stable angina in patients with normal sinus rhythm who have a contraindication or intolerance to beta-blockers.
Unlike beta-blockers, the most common treatment for angina, Procoralan exclusively reduces heart rate and is therefore associated with fewer unwanted effects.
The drug has been studied in more than 5,000 patients and the clinical findings show that Procoralan has both anti-anginal and anti-ischemic efficacy.