Long biased w/ recent settlement with Apotex and tight range.21-May-20 16:10 ET
AMRN
Amarin announces trial to evaluate effects of VASCEPA on patients with COVID-19 (7.28 -0.18)
Amarin today announced support for a clinical trial to investigate the effects of icosapent ethyl (IPE) (VASCEPA) on inflammatory biomarkers and other patient outcomes in individuals with COVID-19. The trial primary endpoint is the effect of VASCEPA versus usual care on high-sensitivity C-reactive protein levels from baseline to 14 days in adults with a COVID-19-positive diagnosis. The clinical study design also includes other endpoints that assess rates and severity of COVID-19 infection in this high-risk group.
The company states, "Based on our current understanding of the biological effects of a COVID-19 infection, including that patients at high risk of cardiovascular disease are at higher risk of mortality and severe effects from a COVID-19 infection, and based on data related to the mechanism of action and effects of VASCEPA in lowering cardiovascular risk in certain high-risk patients, it is believed that VASCEPA could play a beneficial clinical role in helping patients infected by the virus."
14-May-20 14:52 ET
AMRN
Amarin announces VASCEPA data from prespecified and post hoc analyses of REDUCE-IT study (7.64 +0.22)
Amarin today announced that data from the REDUCE-IT study presented at the Society for Cardiovascular Angiography & Interventions 2020 Scientific Sessions,showed that administration of 4 g/day of VASCEPA (icosapent ethyl) resulted in a significant 34% reduction in first coronary revascularizations versus placebo (p<0.0001). Similar reductions of 36% were observed in total, or first and subsequent, revascularizations (p<0.0001).
The analyses from the REDUCE-IT study included several types of coronary revascularization events in statin-treated patients with persistent elevated triglycerides (135-499 mg/dL), who also had either cardiovascular disease or diabetes and additional cardiovascular risk factors.
Prespecified tertiary endpoint analyses showed that times to first revascularization events were significantly reduced by VASCEPA versus placebo across subtypes of intervention, including urgent, emergent, and elective revascularizations, which were reduced by 34% (p<0.0001), 38% (p=0.02), and 32% (p<0.0001), respectively.
In post hoc analyses, VASCEPA significantly reduced percutaneous coronary intervention (PCI) by 32% (p<0.0001) and coronary artery bypass grafting (CABG) by 39% relative to placebo (p=0.0005).
