Good morning, everyone, and welcome to another working week. We hope the weekend was refreshing and relaxing, because that demanding routine of deadlines and meetings has returned. You knew this was inevitable, yes? Well, to cope, perhaps you would like to join us for a cup of stimulation to fortify those nerve endings. We are opting for golden French toast, by the way. So time to get started. Here are some items of interest. Hope your day goes well and do stay in touch …
Esperion Therapeutics (ESPR) reported that a combination of its once-a-day cholesterol pill and a maximum dose of a statin lowered LDL cholesterol 18 percent more than statins alone after 12 weeks, STAT reports. The results come from the last of five successful trials on the drug, called bempedoic acid, whose data the company plans to submit to the Food and Drug Administration in the early months of 2019. To cardiologists, the most important finding related to safety. In the 779-patient study, the drug was indistinguishable from placebo when it came to side effects and deaths.
A bare majority of FDA advisory panel members agreed that cardiovascular outcomes trials, which are used to assess harm by new type 2 diabetes drugs, should continue to be required, but many on the panel called for the process to be streamlined, according to MedPage Today. Despite the close vote, there was nearly unanimous agreement on room for improvement to reduce the burden on drug developers and, in turn, patients.
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