Amarin Corp. PLC hasn't even sought European Medicines Agency (EMA) approval for its purified fish oil therapy Vascepa (icosapent ethyl) to treat hypertriglyceridemia, but already the drug has won an endorsement from the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS) in new dyslipidemia treatment guidelines presented on 2 September at the ESC Congress in Paris.
The ESC/EAS guidelines now state that doctors should consider prescribing Vascepa for patients who have high triglyceride levels despite treatments with statins and who are at high or very high risk for cardiovascular events. The cardiology groups cited Amarin's REDUCE-IT cardiovascular outcomes trial (CVOT), which found that Vascepa on top of statins cut the risk of cardiovascular (CV) events by 25%, including CV death, in patients with baseline triglyceride levels between 135 mg/dL and 499 mg/dL
PCSK9 Inhibitors Also Benefit From Updated ESC/EAS Guidelines
The updated ESC/EAS dyslipidemia guidelines also weighed in on PCSK9 inhibitors, recommending use for very high-risk patients whose LDL does not reach desired levels with statins and now-generic Zetia (ezetimibe) and for patients who are statin-intolerant. Previously the guidelines said doctors should consider prescribing PCSK9-targeting therapies – an endorsement based on a lower level of supporting evidence, which was issued before outcomes data were available for the two approved therapies in this class.
The guidelines also recommend more intensive reduction of LDL levels with revised treatment goals, meaning more aggressive pharmaceutical interventions – like PCSK9 inhibitors – may be needed to bring patients in line with desired LDL levels. Guidelines released in 2016 set an LDL goal of 70 mg/dL or a 50% reduction from baseline for very high-risk patients with a goal of 100 mg/dL or a 50% reduction for high-risk individuals, but now the goals are LDL reductions of at least 50% and 55 mg/dL for very high-risk and 70 mg/dL for high-risk patients.
This is good news for the PCSK9 inhibitor manufacturers – Amgen Inc. with Repatha (evolocumab) and Sanofi/Regeneron Pharmaceuticals Inc. with Praluent (alirocumab) – and for The Medicines Co., which presented its first set of positive Phase III data for inclisiran at the ESC Congress. Inclisiran could have an advantage over its predecessors given its comparable efficacy with twice-yearly dosing instead of once- or twice-monthly injections for Repatha and Praluent. (Also see "Inclisiran’s Safety Data Suggest Game-Changing Potential In PCSK9 Market" - Scrip, 4 September, 2019
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