Good morning, everyone, and welcome to another working week. We hope the weekend respite was relaxing and invigorating, because that oh-so familiar routine of deadlines, online meetings, and phone calls has predictably returned. But what can you do? The world, such as it is, continues to spin. So time to give it a nudge in a better direction by brewing cups of stimulation — and with good reason. Our choice today is magic marshmallow. Can you guess what makes it magical? Meanwhile, here are a few items of interest to start you on your journey, which we hope is meaningful and productive. Best of luck, and do keep in touch. …
A pill designed to further lower cholesterol in people already on statins but at risk of a serious cardiovascular event — their first or a recurrence — reduced LDL cholesterol by up to 60%, a new late-stage trial has found. Two-thirds of patients cut their cholesterol by at least half, STAT tells us. The trial, presented at an American Heart Association meeting on Saturday, fulfills a longtime goal of Merck: to make a pill that achieves LDL cholesterol reductions on par with those obtained with injected monoclonal antibodies. Enlicitide, Merck’s oral, once-daily PCSK9 inhibitor, was tested against a placebo in a Phase 3 clinical trial that enrolled 2,900 people with high levels of LDL, or “bad,” cholesterol. The challenge for Merck’s pill is to match the safety, efficacy, and tolerability shown by the injectable versions of the PCSK9 inhibitor. Merck’s head of research said the goal is to make the pill affordable, The New York Times adds. Only around 1% of eligible patients take the monoclonal antibody injections, which have list prices of more than $500 a month. Many patients do not want to inject themselves, and insurers put up obstacles to paying, cardiologists say.
Meanwhile, one of those cholesterol-lowering injectable medications has now shown its power to cut cardiovascular events in people considered at high risk but who have not yet suffered a heart attack or stroke, STAT explains. A study published in the New England Journal of Medicine and presented at the American Heart Association’s scientific sessions concluded that Amgen’s Repatha reduced coronary heart disease death, heart attack, and stroke by 25% overall and lowered first heart attacks by 36% in people with high cholesterol but no history of these serious events. Their high cholesterol meant they were already taking statins or other cholesterol-lowering medications. Repatha also reduced cardiovascular problems and prevented the need for stent and bypass procedures, meeting both endpoints of the clinical trial. That was better than statin therapy, an older class of cholesterol-lowering drugs that became the best-selling medicines in the world.
Continue to STAT+ to read the full story…
STAT Pharma: The science and business of new drug development
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