Merck Has A Very Promising FDA PRV, For Lowering LDL-C With A Pill: Enlicitide / Phase III CORALreef AddOn Trial Data...

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.

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