{"id":767006,"date":"2026-07-16T21:05:10","date_gmt":"2026-07-16T21:05:10","guid":{"rendered":"https:\/\/www.newsbeep.com\/us\/767006\/"},"modified":"2026-07-16T21:05:10","modified_gmt":"2026-07-16T21:05:10","slug":"fda-signs-off-on-mercks-cholesterol-lowering-pill","status":"publish","type":"post","link":"https:\/\/www.newsbeep.com\/us\/767006\/","title":{"rendered":"FDA signs off on Merck&#8217;s cholesterol-lowering pill"},"content":{"rendered":"<p>The US FDA approved Merck\u2019s\u00a0cholesterol-lowering pill, it said on Thursday, the first in a class of drugs dominated by injections, which could potentially broaden the<a href=\"https:\/\/nypost.com\/2025\/11\/21\/health\/daily-pill-slashes-bad-cholesterol-levels-by-60-in-new-study\/\" rel=\"nofollow noopener\" target=\"_blank\"> use of cholesterol medication <\/a>among people at risk of heart \u200bdisease.<\/p>\n<p>The pill, branded as Lipfendra, is intended to treat patients with hypercholesterolemia, including those with \u200bhereditary forms of the disease, which causes elevated levels of LDL, the <a href=\"https:\/\/nypost.com\/2023\/12\/04\/health\/even-good-cholesterol-is-bad-study-finds-hdl-link-to-dementia\/\" rel=\"nofollow noopener\" target=\"_blank\">so-called \u201cbad\u201d cholesterol<\/a> \u2060in the blood that often leads to plaque buildup in the arteries. About one in four \u200badults in the US have high LDL cholesterol, according to the American Heart Association.<\/p>\n<p>With the US Food \u200band Drug Administration\u2019s approval, Lipfendra, also called enlicitide, would become the first oral treatment from the class of drugs that works by blocking a protein called PCSK9, high levels of which contribute to elevated cholesterol and cardiovascular disease.<\/p>\n<p><img style=\"aspect-ratio:1.52154532;display:block\" loading=\"lazy\" decoding=\"async\" data-modal-image=\"40002428\" width=\"898\" height=\"590\" src=\"https:\/\/www.newsbeep.com\/us\/wp-content\/uploads\/2026\/07\/merck-logo-seen-gate-merck-134567631.jpg\" alt=\"The Merck logo and company name on a brick wall at the entrance to the campus.\" class=\"wp-image-40002428\"  \/>The FDA has approved Merck\u2019s cholesterol-lowering pill Lipfendra. REUTERS<\/p>\n<p>Merck shares rose 4% in morning \u200btrading.<\/p>\n<p>Lipfendra will be sold at a list price of $10.50 a day \u2014 around $315 per month. The company said \u200bthe drug will be available in a matter of weeks.<\/p>\n<p>Merck Executive Vice President Brian Foard said the company plans \u200cto \u2060target patients who are already on cholesterol-lowering treatments like statins to take the drug as an add-on treatment.<\/p>\n<p>\u201cSeventy percent of those patients treated with those therapies are still not achieving guideline recommended goals. We believe this is the opportunity,\u201d Foard said.<\/p>\n<p>RBC Capital Markets analyst Trung Huynh said the drug carries zero contraindications or \u200bhypersensitivity warnings for allergic \u200breactions, unlike currently approved \u2060injectable competitors.<\/p>\n<p>\t\t\t\t\t\t\tStart your day with all you need to know\t\t\t\t\t\t<\/p>\n<p class=\"inline-module__cta\">\n\t\t\t\t\t\t\tMorning Report delivers the latest news, videos, photos and more.\t\t\t\t\t\t<\/p>\n<p>\t\t\t\t\t\tThanks for signing up!\n\t\t\t\t<\/p>\n<p>\u201cDespite a decade of approved injectable options, an estimated 70% (and more) of eligible high-risk atherosclerotic cardiovascular disease patients remain undertreated; driven by injection aversion, \u200bprior authorization burden, and limited specialist access in primary care,\u201d Huynh said.<\/p>\n<p>Huynh projects \u200bLipfendra to \u2060reach peak sales of about $5 billion by 2034.<\/p>\n<p>The FDA\u2019s decision was based on two late-stage trials that showed the once-daily pill lowered LDL cholesterol by nearly 60% in patients with hypercholesterolemia.<\/p>\n<p>An ongoing clinical trial is studying \u2060the \u200beffect of Lipfendra on cardiovascular morbidity and mortality, said Merck.<\/p>\n<p>Other \u200bcholesterol-lowering drugs include PCSK9-inhibitor injectables such as Amgen\u2019s Repatha, and Regeneron\u00a0and Sanofi\u2019s\u00a0Praluent.<\/p>\n","protected":false},"excerpt":{"rendered":"The US FDA approved Merck\u2019s\u00a0cholesterol-lowering pill, it said on Thursday, the first in a class of drugs dominated&hellip;\n","protected":false},"author":2,"featured_media":767007,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[59],"tags":[28,246,97,252,253,134305,247,673],"class_list":["post-767006","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health-care","tag-business","tag-fda","tag-health","tag-health-care","tag-healthcare","tag-merck-co","tag-pharmaceuticals","tag-wellness"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/767006","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/comments?post=767006"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/posts\/767006\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media\/767007"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/media?parent=767006"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/categories?post=767006"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/us\/wp-json\/wp\/v2\/tags?post=767006"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}