There can be no doubt: high cholesterol (and the diseases it engenders) are certainly a public health calamity, especially in the rural US. So, having a pill — as opposed to an injection — would be a huge step forward. [BTW, here’s just one of several prior backgrounders of mine, on this oral compound.] Late last year, the FDA granted the compound a priority review voucher, so it might reach market now even before year end 2026.
And that will be excellent news — for prescribing general practice / family doctors, and their high LDL-C patients across the nation. In rural America, there will be no need to see a specialist before switching meds. Here’s a bit of all of this, from BioSpace:
…At ACC, Merck reviewed results from its Phase III CORALreef AddOn study, in which enlicitide demonstrated a statistically significant reduction in LDL-C after eight weeks of treatment compared to current cholesterol-lowering medicines bempedoic acid, ezetimibe or bempedoic acid with ezetimibe….
Joerg Koglin, senior vice president, global clinical development at Merck, told BioSpace… “When you look at the LDL goals as they are right now, approximately 70% of patients on statins don’t reach those goals….”
And so — gone forever are the days of “very expensive placebos” like old SGP’s Vytorin. What a train wreck Fred Hassan was, about 18 years ago now. Dang. It is… indeed, a new day in America. Smile.
नमस्ते
