{"id":1712,"date":"2024-03-16T15:34:37","date_gmt":"2024-03-16T15:34:37","guid":{"rendered":"https:\/\/healthyretirementnews.com\/index.php\/2024\/03\/16\/fda-approves-first-drug-for-common-form-of-liver-inflammation\/"},"modified":"2024-03-16T15:34:37","modified_gmt":"2024-03-16T15:34:37","slug":"fda-approves-first-drug-for-common-form-of-liver-inflammation","status":"publish","type":"post","link":"https:\/\/healthyretirementnews.com\/index.php\/2024\/03\/16\/fda-approves-first-drug-for-common-form-of-liver-inflammation\/","title":{"rendered":"FDA approves first drug for common form of liver inflammation"},"content":{"rendered":"<div>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltropj0a00524wqkfrged1iv@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The US Food and Drug Administration has\u00a0approved\u00a0the first medication for a common form of liver inflammation called nonalcoholic steatohepatitis, or NASH, the agency said Thursday.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00023b6hrfmdpcwj@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            NASH \u2014 also known as metabolic dysfunction-associated steatohepatitis, or MASH \u2014 happens when the liver becomes inflamed because of excess fat cells that build up in the liver, leading to inflammation and scarring. It\u2019s an advanced form of nonalcoholic fatty liver disease; the disease is closely associated with obesity, type 2 diabetes and a variety of other metabolic conditions such as high blood pressure. About 6 million to 8 million people in the US are thought to have NASH with moderate to advanced liver fibrosis, or scarring, the FDA says. Other complications associated with the condition include cirrhosis, liver failure and liver cancer.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00033b6h3jqjgkew@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Up until now, there was no medication to treat the disease. Previous NASH treatment regimens focused on weight loss through lifestyle changes such as blood sugar control, a healthy diet and regular exercise.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00043b6hhydkuur3@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The new medication, Madrigal Pharmaceuticals\u2019 resmetirom, will be marketed under the brand name Rezdiffra. It received Breakthrough Therapy designation from the FDA in April. This status expedites the development and review of drugs that are intended to treat a serious condition and that preliminary clinical evidence indicates may be a substantial improvement over available therapies.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00053b6hd3cu7tyu@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            The medication \u2014 which activates a thyroid hormone receptor in the liver to help reduce fat accumulation \u2014 is taken by mouth daily. It\u2019s approved for people who have NASH with moderate to advanced fibrosis, and it\u2019s intended to be used along with a healthy diet and exercise.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00063b6hv0h7g1ce@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Clinical trial\u00a0results\u00a0published in February showed that more than 25% of participants taking 80 milligrams of resmetirom achieved NASH resolution with no worsening of fibrosis, as did almost 30% of those taking 100 mg and less than 10% of participants who got a placebo. The medication also helped lower LDL or \u201cbad\u201d cholesterol levels and liver enzyme levels.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltstb0ln000a336hirs5o7o3@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            It\u2019s still not clear yet how long patients will need to take the medication. More research is needed.    <\/p>\n<div data-uri=\"cms.cnn.com\/_components\/factbox\/instances\/cltrow0d8000f3b6hhmb1lbsz@published\" class=\"factbox_inline-small         factbox_inline-small__standard  \" data-article-gutter=\"true\">\n<ul class=\"factbox_inline-small__items factbox_inline-small__items--ul\">  <\/ul>\n<\/div>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00073b6hwiwsn714@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Most of the adverse events reported in the trial were mild or moderate; diarrhea and nausea were most common. Rezdiffra can have \u201cpotentially significant\u201d interactions with certain other drugs, most notably statins to lower cholesterol, the FDA noted.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00083b6huk3fpcjl@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Rezdiffra received what\u2019s known as accelerated approval, and Madrigal must complete a post-approval study to verify the drug\u2019s clinical benefit.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrovnsb00093b6hyfizhorw@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cI believe this approval milestone will bring new energy and momentum to the NASH community, accelerating our efforts to improve disease education, build care pathways, and expand investment in NASH research,\u201d Wayne Eskridge, CEO of the Fatty Liver Foundation, said in a\u00a0news release\u00a0from Madrigal on Thursday.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltrp3hnm00033b6hrxaaglhq@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Madrigal says that it expects Rezdiffra to be available next month and that it has set up an assistance program to help people who don\u2019t have insurance access the drug.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltstbpr3000c336h3oibcu0r@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            Dr. Pierre Gholam, a hepatologist at University Hospitals in Cleveland, said he hopes the approval of this drug will be the first of many that can improve the outcome of this disease. He\u2019s happy he will finally have something to offer his patients with this disease.    <\/p>\n<p class=\"paragraph inline-placeholder\" data-uri=\"cms.cnn.com\/_components\/paragraph\/instances\/cltsswf500001336htpdvd2pa@published\" data-editable=\"text\" data-component-name=\"paragraph\" data-article-gutter=\"true\">            \u201cIt\u2019s definitely a game-changer in that we have been trying to find a drug that works and that the FDA will approve in the broad category of steatotic liver disease or fatty liver disease for more than 15 years, but so far every drug that\u2019s ever developed for this ended up not being approved,\u201d Gholam said. \u201cSo it\u2019s a very big deal.\u201d    <\/p>\n<\/p>\n<div>This post appeared first on cnn.com<\/div>\n<\/div>\n<p><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The US Food and Drug Administration has\u00a0approved\u00a0the first medication for a common form of liver&hellip;<\/p>\n","protected":false},"author":1,"featured_media":1713,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-1712","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-health-news"],"_links":{"self":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts\/1712","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/comments?post=1712"}],"version-history":[{"count":0,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/posts\/1712\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/media\/1713"}],"wp:attachment":[{"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/media?parent=1712"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/categories?post=1712"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/healthyretirementnews.com\/index.php\/wp-json\/wp\/v2\/tags?post=1712"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}