Merck said on Thursday the Food and Drug Adminstration has approved its cholesterol pill, the first of its kind to receive the health regulator\u2019s nod, bolstering the drugmaker\u2019s efforts to diversify beyond its blockbuster cancer treatment Keytruda.<\/p>\n
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Keytruda is set to lose key patent protections starting in 2028, exposing the company to competition from potential less expensive biosimilar versions of the drug.<\/p>\n
The pill Lipfendra is intended to treat patients with hypercholesterolemia, which can be identified by elevated levels of LDL<\/a>, the so-called \u201cbad\u201d cholesterol in the blood, often leading to plaque buildup in the arteries.<\/p>\n With the FDA\u2019s approval, Lipfendra, also called enlicitide, would become the first oral PCSK9 inhibitor to enter the market, offering an alternative to a class of cholesterol-lowering drugs long dominated by injectables.<\/p>\n Its list price will be $10.50 per day, based on a 30-day supply, Merck told Reuters. The company\u2019s shares were up 1.1% in premarket trading.<\/p>\n Lipfendra works by blocking PCSK9 protein<\/a>, which plays a vital role in regulating cholesterol levels, while oral statins<\/a>, an older type of cholesterol medicine, block an enzyme the liver uses to make cholesterol.<\/p>\n About one in four adults in the U.S. have high LDL cholesterol, according to the American Heart Association.<\/p>\n The FDA\u2019s decision was based on two late-stage trials, which showed the once-daily pill significantly lowered LDL cholesterol in a broad range of patients, including those with familial hypercholesterolemia and those already taking statins.<\/p>\n The landscape for cholesterol-lowering drugs is currently dominated by PCSK9-inhibitor injectables such as Amgen\u2019s Repatha, and Regeneron and Sanofi\u2019s Praluent.<\/p>\n Lipfendra could have \u201cpeak sales potential of tens of billions of dollars,\u201d Scotiabank analyst Louise Chen had said ahead of the approval.<\/p>\n Merck\u2019s drug is a recipient of the FDA commissioner\u2019s National Priority Voucher program, which is intended to slash review periods of drugs that are critical to public health or national security.<\/p>\n","protected":false},"excerpt":{"rendered":"Merck said on Thursday the Food and Drug Adminstration has approved its cholesterol pill, the first of its…\n","protected":false},"author":2,"featured_media":694958,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[42],"tags":[102,6591,56,54,55],"class_list":["post-694957","post","type-post","status-publish","format-standard","has-post-thumbnail","category-medication","tag-health","tag-medication","tag-uk","tag-united-kingdom","tag-unitedkingdom"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/694957","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/comments?post=694957"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/posts\/694957\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media\/694958"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/media?parent=694957"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/categories?post=694957"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/uk\/wp-json\/wp\/v2\/tags?post=694957"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}