{"id":22027,"date":"2019-02-13T15:23:45","date_gmt":"2019-02-13T20:23:45","guid":{"rendered":"https:\/\/www.med.unc.edu\/medicine\/?post_type=episode&#038;p=22027"},"modified":"2023-08-04T13:57:02","modified_gmt":"2023-08-04T17:57:02","slug":"galafold","status":"publish","type":"episode","link":"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/galafold\/","title":{"rendered":"Galafold &#8211; with Jerry Walter &amp; Dr. Gerald Hladik"},"content":{"rendered":"<figure id=\"attachment_22029\" class=\"thumbnail wp-caption alignright\" style=\"width: 177px\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-22029 \" src=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2019\/02\/5eaef4d4-3405-4ca1-9d54-bbdf170d6b17.jpeg\" alt=\"\" width=\"167\" height=\"209\" \/><figcaption class=\"caption wp-caption-text\">Jerry Walter<\/figcaption><\/figure>\n<figure id=\"attachment_22028\" class=\"thumbnail wp-caption alignright\" style=\"width: 210px\"><img loading=\"lazy\" decoding=\"async\" class=\"wp-image-22028 size-full\" src=\"https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2019\/02\/27f6a4a4-3975-4af0-ba0e-bb1d759e17a5.jpeg\" alt=\"\" width=\"200\" height=\"250\" \/><figcaption class=\"caption wp-caption-text\">Gerald Hladik, MD<\/figcaption><\/figure>\n<p>Galafold (migalastat) was approved in August 2018 for the treatment of Fabry disease. Jerry Walter, a patient who has Fabry, and his nephrologist, Dr. Gerald Hladik, discuss how the drug works, and common concerns and questions patients have about the treatment. Dr. Hladik is the Doc J Thurston Distinguished Professor of Medicine and Chief of the UNC Division of Nephrology and Hypertension.<\/p>\n<div class=\"alert alert-gray\">\n<p>\u201cMigalastat, or Galafold, is the first oral medication available for the treatment of Fabry\u2019s disease in individuals with amenable mutations. It\u2019s dosed every other day, which is much more convenient than the intravenous enzyme replacement therapy.\u201d<\/p>\n<p>\u2013 Dr. Gerald Hladik\n<\/p><\/div>\n<!--[if lt IE 9]><script>document.createElement('audio');<\/script><![endif]-->\n\t<div class=\"wp-playlist wp-audio-playlist wp-playlist-light\">\n\t\t\t<div class=\"wp-playlist-current-item\"><\/div>\n\t\t<audio controls=\"controls\" preload=\"none\" width=\"1118\"\n\t\t\t><\/audio>\n\t<div class=\"wp-playlist-next\"><\/div>\n\t<div class=\"wp-playlist-prev\"><\/div>\n\t<noscript>\n\t<ol>\n\t\t<li><a class=\"thumbnail img-thumbnail\" href='https:\/\/www.med.unc.edu\/medicine\/wp-content\/uploads\/sites\/945\/2019\/03\/galafold.mp3'>Galafold - with Jerry Walter &amp; Dr. Gerald Hladik<\/a><\/li>\t<\/ol>\n\t<\/noscript>\n\t<script type=\"application\/json\" class=\"wp-playlist-script\">{\"type\":\"audio\",\"tracklist\":true,\"tracknumbers\":true,\"images\":true,\"artists\":true,\"tracks\":[{\"src\":\"https:\\\/\\\/www.med.unc.edu\\\/medicine\\\/wp-content\\\/uploads\\\/sites\\\/945\\\/2019\\\/03\\\/galafold.mp3\",\"type\":\"audio\\\/mpeg\",\"title\":\"Galafold - with Jerry Walter &amp; Dr. Gerald Hladik\",\"caption\":\"\",\"description\":\"\\\"Galafold - with Jerry Walter &amp; Dr. Gerald Hladik\\\" from Galafold - with Jerry Walter &amp; Dr. Gerald Hladik by UNC Department of Medicine - Dr. Ron Falk. Released: 2018. Genre: Intro.\",\"meta\":{\"artist\":\"UNC Department of Medicine - Dr. Ron Falk\",\"album\":\"Galafold - with Jerry Walter &amp; Dr. Gerald Hladik\",\"genre\":\"Intro\",\"year\":\"2018\",\"length_formatted\":\"13:28\"},\"image\":{\"src\":\"https:\\\/\\\/www.med.unc.edu\\\/medicine\\\/wp-content\\\/plugins\\\/media-library-assistant\\\/images\\\/crystal\\\/audio.png\",\"width\":48,\"height\":64},\"thumb\":{\"src\":\"https:\\\/\\\/www.med.unc.edu\\\/medicine\\\/wp-content\\\/plugins\\\/media-library-assistant\\\/images\\\/crystal\\\/audio.png\",\"width\":48,\"height\":64}}]}<\/script>\n<\/div>\n\t\n<p><b>Ron Falk: <\/b>Hello, and welcome to the Chair\u2019s Corner from the Department of Medicine at the University of North Carolina.<\/p>\n<p>We are beginning a new series talking about novel therapies. We\u2019ll get to hear from experts in several divisions in our department, who will tell us about treatments that have recently been approved by the Food and Drug Administration, otherwise known as the FDA. We\u2019ll explain the drug\u2019s effectiveness, side effects, and concerns and questions that people have raised.<\/p>\n<p>Today we will discuss Galafold, a new treatment for Fabry disease. We recently discussed Fabry in <a class=\"internal-link\" title=\"\" href=\"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/fabry-disease\/\">our last episode<\/a>, so if you haven\u2019t checked that out, you may want to do so before you listen to this podcast. In it, we talked with a patient who has Fabry, Jerry Walter, and his kidney doctor, <a class=\"external-link\" title=\"\" href=\"https:\/\/www.med.unc.edu\/medicine\/directory\/gerald-hladik\/\" target=\"_blank\" rel=\"noopener noreferrer\">Dr. Gerald Hladik<\/a>.<\/p>\n<p>We welcome them both back today: Jerry Walter, who is a retired United States Army Colonel, has Fabry disease. He also is the founder and president of the <a class=\"external-link\" title=\"\" href=\"https:\/\/www.fabrydisease.org\" target=\"_blank\" rel=\"noopener noreferrer\">National Fabry Disease Foundation<\/a>.<\/p>\n<p>We also welcome back Dr. Gerald Hladik, who is the Doc J. Thurston Distinguished Professor of Medicine and Chief of the Division of Nephrology and Hypertension at UNC.<\/p>\n<p>Thank you both for talking with us again.<\/p>\n<p><b>Walter: <\/b>Thanks, Dr. Falk.<\/p>\n<p><b>Hladik: <\/b>Thank you.<\/p>\n<h3><span class=\"blue\">How Galafold works<\/span><\/h3>\n<p><b>Falk: <\/b>Dr. Hladik<b>, <\/b>please tell us a little bit about Galafold and when it was approved.<\/p>\n<p><b>Hladik: <\/b>On August 10 of 2018, the medical and Fabry community were excited to learn that the FDA finally approved Galafold, or migalastat, as it\u2019s known, for the treatment of Fabry\u2019s disease.<\/p>\n<p><b>Falk: <\/b>And how does that medicine work?<\/p>\n<p><b>Hladik: <\/b>Well, it\u2019s a chaperone molecule. So, you know that a chaperone on a date is somebody who comes along as a guide and to observe, and in this case, the drug is the chaperone. With Fabry\u2019s disease, there\u2019s an abnormal enzyme, and that abnormal enzyme is chaperoned into the lysosome\u2014that part of the cellular machinery where it needs to localize to be effective in breaking down fatty molecules.<\/p>\n<p><b>Falk: <\/b>In the last episode, we learned that Fabry\u2019s disease is caused by a deficiency in an enzyme. Remind us what that enzyme is called?<\/p>\n<p><b>Hladik: <\/b>The enzyme is alpha-galactosidase A, and the gene that encodes this protein is called GLA. Remember that the level of this enzyme is quite low in Fabry patients, leading to impaired clearance of GL3 (globotriaosylceramide).<\/p>\n<p><b>Falk: <\/b>The chaperone helps alpha-galactosidase now get into the cell?<\/p>\n<p><b>Hladik: <\/b>It stabilizes the enzyme so that it can more readily enter into the \u201cdigestive system\u201d of the cell, the lysosome, where can effectively break down GL3.<\/p>\n<p><b>Falk: <\/b>Even if you have a very small amount of the enzyme, whatever amount of enzyme you have now works better than it did by itself.<\/p>\n<p><b>Hladik: <\/b>Precisely.<br \/>\n<b><\/b><\/p>\n<p><b>Falk: <\/b>This molecule then joins forces with the enzyme to get into the cell, to have the enzyme work.<\/p>\n<p><b>Hladik: <\/b>That\u2019s right.<\/p>\n<p><b>Falk: <\/b>What patient will this drug be best used for?<\/p>\n<p><b>Hladik: <\/b>Well, unfortunately it turns out the drug is not effective in every patient with Fabry disease. About thirty to fifty percent of people with the disease are candidates for this drug. This is determined by the specific mutation a person has, or in the case of novel mutations, a bioassay can test whether or not the drug will be effective in clearing GL3.<\/p>\n<p><b>Falk: <\/b>Are there any side effects associated with this drug?<\/p>\n<p><b>Hladik: <\/b>There are. Now, one of the big breakthroughs of this medicine is it\u2019s the first oral medication available for the treatment of Fabry\u2019s disease. It\u2019s dosed every other day, so that\u2019s much more convenient than the classic treatment, which is treating by replacing the missing enzyme. Remember, that\u2019s an infusion that patients have to receive every two weeks.<\/p>\n<h3><span class=\"blue\">Enzyme replacement therapy<\/span><\/h3>\n<p><b>Falk: <\/b>There is an enzyme replacement therapy. Can you tell us a little bit about that?<\/p>\n<p><b>Hladik: <\/b>Yes, well there are two products on the market. One is called Fabrazyme, the other is Replagal. Fabrazyme is available in the US. It\u2019s an infusion, basically the enzyme \u2013 alpha-galactosidase A, that\u2019s infused every two weeks.<\/p>\n<p><b>Falk: <\/b>And the advantages and disadvantages of that molecule, for that drug?<\/p>\n<p><b>Hladik: <\/b>Well, the advantage is you\u2019re replacing what\u2019s defective, and there\u2019s good evidence showing that it\u2019s quite effective, particularly when started early.<\/p>\n<p><b>Falk: <\/b>The downside is you have to have an intravenous infusion, every two weeks throughout your entire life.<\/p>\n<p><b>Hladik: <\/b>That\u2019s right. How long does that infusion take, Jerry?<\/p>\n<p><b>Walter: <\/b>Mine takes about four hours at the moment. I\u2019ve gotten down as quick as three hours and fifteen minutes. I started out in clinical trials in 2002, and you start with a five to six-hour infusion, then you progressively step up the rate. According to the label, you can get down to about a two-hour infusion, but everyone\u2019s body doesn\u2019t like it that fast.<\/p>\n<h3><span class=\"blue\">Side effects and effectiveness of Galafold<\/span><b> <\/b><\/h3>\n<p><b>Falk: <\/b>The advantage of Galafold, is that it\u2019s an oral medication. You take it by mouth. What are the side effects of Galafold?<\/p>\n<p><b>Hladik: <\/b>The most common one is headache. It can also cause nose and throat irritation. There are some reports of urinary tract infection and febrile reactions.<\/p>\n<p><b>Falk: <\/b>How effective is it for the individuals for whom it\u2019s going to work?<\/p>\n<p><b>Hladik: <\/b>For patients who have what are called \u201camenable mutations,\u201d\u2014those are the patients for whom the drug is going to work\u2014it appears to be very effective. There are now two trials showing equal efficacy with enzyme replacement therapy, at least in the short term.<\/p>\n<p>It\u2019s important to note that this drug was approved by the FDA\u2019s accelerated approval pathway, so it\u2019s emerged from clinical trials relatively early, which is great for patients, but we do need further confirmatory studies to document efficacy in the long term.<\/p>\n<p><b>Falk: <\/b>How do you as a physician know that this drug is doing what it\u2019s supposed to do?<\/p>\n<p><b>Hladik: <\/b>Well, you can follow symptoms. For example, if a patient was having painful crises in the past and they went away with enzyme replacement therapy, and the symptoms return after changing to Galafold, that would be a concern.<\/p>\n<p><b>Falk: <\/b>What would be a reason that a patient would stop taking Galafold?<\/p>\n<p><b>Hladik:<\/b>The most obvious reason would be if they\u2019re having intolerable side effects, such as headache. Next would be evidence of treatment failure, such as an acceleration in their symptoms, or signs of progressive organ injury.<\/p>\n<p><b>Falk: <\/b>Colonel Walter, could you tell us about all the therapies you have had for Fabry\u2019s?<\/p>\n<p><b>Walter: <\/b>Well, for myself I\u2019ve only had enzyme replacement therapy personally. I started on my birthday in 2002. So, I\u2019ve been on enzyme replacement therapy every two weeks for almost sixteen years. For me, I think it\u2019s saved my life. I think it\u2019s kept my kidneys stable, I think it has improved my heart clinically\u2014I don\u2019t think, I know it has improved my heart clinically. Even though I still have heart issues, I didn\u2019t start therapy until I was forty-eight years old. In my case I had been very fortunate.<\/p>\n<p>I\u2019ve lost several family members to Fabry disease before treatment was available, under the age of fifty, which is the statistical prediction. When I learned I had Fabry disease, I the average death of an untreated male was only forty-one. Later on, through dialysis and transplant, it became fifty. Now it\u2019s cited as fifty-eight years old for average age of death\u2014but not for untreated, because now we have so many people getting treated. Average age of death in general is fifty-eight.<\/p>\n<h3><span class=\"blue\">Concerns and issues<\/span><\/h3>\n<p><b>Falk: <\/b>When you heard that Galafold was approved by the FDA, what were your reactions?<\/p>\n<p><b>Walter: <\/b>Well, my reaction from a community standpoint is it\u2019s very exciting and great news. Personally, I have a deletion mutation, which means I\u2019m missing part of the gene and Galafold won\u2019t work on people who have deletion or insertion genes, an extra part or a missing part, but it will work on a certain type of mutation, that of Dr. Hladik spoke of, it will only work for a certain percentage.<\/p>\n<p>But for those people, it\u2019s exciting because it\u2019s easier to take. You take a capsule every other day, in lieu of biweekly IVs, which is tremendous. Travel time, and convenience of not having to leave work or leave school for an IV infusion are definitely huge benefits. We\u2019ll just wait and see how effective it is for those taking it. It\u2019s very promising.<\/p>\n<p><b>Falk: <\/b>Have you heard any concerns from any individuals in your foundation, or patients?<\/p>\n<p><b>Walter: <\/b>The biggest concern is that everyone can\u2019t take it. We have this new product on the market and it\u2019s only good for a certain percentage of our population. Everyone wishes they could take a shot at it and see if they would be better.<\/p>\n<p>But in terms of the medication itself, I haven\u2019t heard any concerns about serious reactions or problems. We\u2019ll learn, even though it seems simpler, whether compliance taking the medication is an issue or not. There are some restrictions, like not eating two hours before or after, of taking it every other day, so we\u2019ll see how all that turns out.<\/p>\n<p><b>Falk: <\/b>What suggestions do you have for someone with Fabry\u2019s disease who is just starting enzyme replacement therapy, or other treatments, including Galafold?<\/p>\n<p><b>Walter: <\/b>Well, I think we\u2019ve learned that it\u2019s not a one-size-fits-all disease or one-size-fits-all treatment, so I think enzyme replacement therapy is going to work very well for many people. They may choose it over the easier one\u2014or they may not have a choice if they can\u2019t take it\u2014but even some people have elected to continue taking enzyme replacement therapy. That may be because it\u2019s so new they\u2019re not ready to make that switch.<\/p>\n<p>I think everyone just has to figure out what best works for them. We know there are people who can\u2019t take enzyme replacement therapy, due to infusion-related reactions or other problems. We know already that there may be some people who can\u2019t take Galafold for various reasons. We think it\u2019s just something we\u2019ll learn over time.<\/p>\n<p><b>Falk: <\/b>What other questions or issues do you think people would want us to talk about, about Galafold?<\/p>\n<p><b>Walter: <\/b>What we hear a lot, and the questions we hear are, <i>\u201cHow can I get my mutation tested?\u201d <\/i>Or, <i>\u201cHow do I take the first step in getting treatment?\u201d <\/i>Some people are having problems with insurance. Insurance, for one reason or another, doesn\u2019t want to make the change to pay for Galafold. So, all of those issues have to be worked out, so that everyone gets what works best for them.<\/p>\n<h3><span class=\"blue\">New drugs on the horizon<\/span><\/h3>\n<p><b>Falk: <\/b>Are there new drugs that are on the horizon?<\/p>\n<p><b>Walter: <\/b>In addition to the two treatments that we now have, and three in Europe\u2014a second enzyme replacement therapy, in other countries, we\u2019ve got two substrate reduction therapies being worked on, where the drug would make your body produce less substrate, produce less GL3, and therefore you don\u2019t have to get rid of as much.<\/p>\n<p>Then, there\u2019s three gene therapies in progress right now\u2014three different solutions. We still have a lot to look forward to. The gene therapy solution, is in theory, a one-time deal. You take the medication and you\u2019ve cured Fabry disease in that sense.<\/p>\n<p><b>Falk: <\/b>Wouldn\u2019t that be wonderful?<\/p>\n<p><b>Walter: <\/b>It would.<\/p>\n<p><b>Falk: <\/b>Especially in children.<b> <\/b><\/p>\n<p><b>Walter: <\/b>We have so much to look forward to. We\u2019re fortunate as it is, to have treatments available. As I\u2019ve said before, our prognosis is so much brighter.<\/p>\n<p><b>Falk: <\/b>Thank you, Jerry Walter and Jerry Hladik, for joining us today.<\/p>\n<p><b>Walter: <\/b>It\u2019s really been a pleasure. I\u2019m always anxious to further our cause and spread awareness of Fabry disease and its treatments.<\/p>\n<p><b>Hladik: <\/b>Thanks so much.<\/p>\n<p><b>Falk: <\/b>Thanks so much to our listeners for tuning in. Our next episode in this series will be on new diabetes treatments with Dr. John Buse.<\/p>\n<p>You can subscribe to the Chair\u2019s Corner on <a href=\"https:\/\/itunes.apple.com\/us\/podcast\/unc-department-of-medicine-chairs-corner\/id1076686662?mt=2\" target=\"_blank\" rel=\"noopener noreferrer\">iTunes<\/a>, <a href=\"https:\/\/soundcloud.com\/chairscorner\" target=\"_blank\" rel=\"noopener noreferrer\">SoundCloud<\/a>, or <a href=\"https:\/\/www.facebook.com\/UNCDeptMedicine\" target=\"_blank\" rel=\"noopener noreferrer\">like us on FaceBook<\/a>. Thanks so much for listening.<\/p>\n<div><\/div>\n<div class=\"alert alert-blue width:100% \">\n<ul>\n<li><a class=\"external-link\" title=\"\" href=\"https:\/\/www.med.unc.edu\/medicine\/directory\/gerald-hladik\/\" target=\"_blank\" rel=\"noopener noreferrer\">Dr. Gerald Hladik&#8217;s School of Medicine profile<\/a><\/li>\n<li><a class=\"internal-link\" title=\"\" href=\"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/fabry-disease\/\">Fabry disease podcast episode<\/a> featuring Jerry Walter &amp; Dr. Gerald Hladik<\/li>\n<li>National Fabry Disease Foundation:<br \/>\n<a class=\"external-link\" title=\"\" href=\"https:\/\/www.fabrydisease.org\" target=\"_blank\" rel=\"noopener noreferrer\">Website,<\/a> <a class=\"external-link\" title=\"\" href=\"http:\/\/www.facebook.com\/FabryDisease\" target=\"_blank\" rel=\"noopener noreferrer\">Facebook<\/a>, <a class=\"external-link\" title=\"\" href=\"http:\/\/www.twitter.com\/FabryDisease1\" target=\"_blank\" rel=\"noopener noreferrer\">Twitter<\/a>, <a class=\"external-link\" title=\"\" href=\"http:\/\/www.youtube.com\/user\/TheNFDF\" target=\"_blank\" rel=\"noopener noreferrer\">YouTube<\/a><\/li>\n<\/ul>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Galafold (migalastat) was approved in August 2018 for the treatment of Fabry disease. Jerry Walter, a patient who has Fabry, and his nephrologist, Dr. Gerald Hladik, discuss how the drug works, and common concerns and questions patients have about the treatment. Dr. Hladik is the Doc J Thurston Distinguished Professor of Medicine and Chief of &hellip; <a href=\"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/galafold\/\" aria-label=\"Read more about Galafold &#8211; with Jerry Walter &amp; Dr. Gerald Hladik\">Read more<\/a><\/p>\n","protected":false},"featured_media":0,"menu_order":0,"template":"","meta":{"_acf_changed":false,"layout":"","cellInformation":"","apiCallInformation":"","_links_to":"","_links_to_target":""},"podcast-category":[664,639,637],"class_list":["post-22027","episode","type-episode","status-publish","hentry","podcast-category-podcast-patient-stories","podcast-category-podcast","podcast-category-podcast-talking-about-treatments","odd"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v26.8 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Galafold - with Jerry Walter &amp; Dr. Gerald Hladik | Department of Medicine<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.med.unc.edu\/medicine\/news\/chairs-corner\/podcast\/galafold\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Galafold - with Jerry Walter &amp; Dr. Gerald Hladik | Department of Medicine\" \/>\n<meta property=\"og:description\" content=\"Galafold (migalastat) was approved in August 2018 for the treatment of Fabry disease. Jerry Walter, a patient who has Fabry, and his nephrologist, Dr. Gerald Hladik, discuss how the drug works, and common concerns and questions patients have about the treatment. 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