{"id":5536,"date":"2017-10-06T13:36:20","date_gmt":"2017-10-06T13:36:20","guid":{"rendered":"https:\/\/laforcedmd.com\/?p=5536\/"},"modified":"2022-05-03T18:20:20","modified_gmt":"2022-05-03T18:20:20","slug":"fda-advisory-committee-adcom-hears-voice-dmd-community","status":"publish","type":"post","link":"https:\/\/laforcedmd.com\/en\/fda-advisory-committee-adcom-hears-voice-dmd-community\/","title":{"rendered":"FDA Advisory Committee (AdCom) hears the voice of the DMD community"},"content":{"rendered":"<p>On September 28, 2017, the U.S. Food and Drug Administration (FDA) held an Advisory Committee (AdCom) meeting to discuss the new drug application for ataluren for oral suspension (PTC Therapeutics Inc.). This committee allows stakeholders to present additional data, information and views on treatment. At the end of this hearing, the AdCom voted that more data is needed to prove that ataluren works in children with Duchenne muscular dystrophy (DMD).<\/p>\n<h3><strong>About the results of the vote<\/strong><\/h3>\n<p>The FDA Peripheral and Central Nervous System Drugs Advisory Committee voted overwhelmingly that efficacy data, supporting the PTC Therapeutics Inc. application for marketing approval of ataluren, was inconclusive (10 of 11 votes). Only one vote supported the position that clinical research data showed that ataluren was effective in children with DMD due to a nonsense mutation in the dystrophin gene.<\/p>\n<p>Overall, this vote means that the FDA will continue their conversation with PTC Therapeutics Inc. The information presented to the AdCom will be considered as part of the company\u2019s total submission for marketing approval.<\/p>\n<h3><strong>La Force meets the DMD community <\/strong><\/h3>\n<p>The La Force team was present at the AdCom meeting. We interviewed many families whose children with DMD have been on ataluren. They were all very positive about the benefits, and they felt that the FDA heard them. This blog gives an overview of what they had to say about the event, the benefits of treatment, and their reactions to the decision.<\/p>\n<p><iframe loading=\"lazy\" title=\"FDA Advisory Committee (AdCom) hears the voice of the DMD community\" width=\"1140\" height=\"641\" src=\"https:\/\/www.youtube.com\/embed\/J3qcd2aNadI?feature=oembed\" frameborder=\"0\" allow=\"accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture\" allowfullscreen><\/iframe><\/p>\n<h3><\/h3>\n<h3><strong>The role of families at the AdCom<\/strong><\/h3>\n<p>Being able to complete a Lego set. Having more global energy to study. These incalculable benefits rarely emerge from clinical research data. To go beyond the data, the AdCom heard patient and expert testimonials.<\/p>\n<p><strong>\u00a0<\/strong><\/p>\n<h5>Betty Vertin, mother of three boys with DMD<\/h5>\n<blockquote><p>\u201cBasically, it is a meeting that gives us an opportunity to put a case together in front of the FDA. They looked at the data, for them, and the data did not make a convincing argument that ataluren worked. So, they pulled in this group of experts. Basically, <strong>they\u2019re giving us our day in court and we can put a face to the data and show what benefit really looks like<\/strong>.\u201d<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h3><strong>A<\/strong><strong>bout overall benefits<\/strong><\/h3>\n<p>Many benefits cannot be calculated by clinical research data. For example, for a boy with DMD, having more global energy to study is life changing. This is the reason why testimonials from children and young adults are very important at AdCom meetings.<\/p>\n<h5><strong>\u00a0<\/strong><\/h5>\n<h5>Darrell Knight, father of Jack Knight, a 17-year-old with DMD<\/h5>\n<blockquote><p>\u201cLike I said, it varies from boy to boy, but most boys will usually lose their ability to walk and be in a wheelchair by the time they\u2019re 8 years of age. Roughly around that area. My son was 14, almost 15 years of age. <strong>Did that have to do with the drug? We believe so<\/strong>.\u201d<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h3><strong>Making more treatments available<\/strong><\/h3>\n<p>Eteplirsen is only approved for a small fraction of patients with DMD. The only other FDA-approved therapy, the corticosteroid Emflaza\u2122 (deflazacort), isn\u2019t a cure. Every treatment that gets marketing approval helps to move towards a cure and encourages the pharmaceutical industry to invest in finding new DMD therapies.<\/p>\n<h5>Betty Vertin, mother of three boys with DMD<\/h5>\n<blockquote><p>\u201cGetting one more through the door, getting one more approved, opens up the door. More companies are going to invest in Duchenne and be willing to go to bat for us, and <strong>those boys deserve that opportunity<\/strong>. So, even though this is a win for a small population of boys who will get access to the drug, it would be an even bigger win for the community.\u201d<\/p><\/blockquote>\n<h5>Darrell Knight, father of Jack Knight, a 17-year-old with DMD<\/h5>\n<blockquote><p>\u201cI think the FDA is looking for that home run ball, that in-the-park, grand-slam home run. For us, it\u2019s not that at all. For us, it\u2019s base hits. If we get a base hit here, a base hit there, we\u2019re going to be in the ball game. We have to have the base hits, where they\u2019re looking for the home runs. I think, if we can get them convinced that a base hit is worth it, then I think, we\u2019re going to be moving on and I think it\u2019s going to be very encouraging.\u201d<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h3><strong>Voices from the DMD community <\/strong><\/h3>\n<p>The AdCom listened to voices from the DMD community. What they heard was compelling. Even if the clinical data didn\u2019t convince them of this drug\u2019s efficacy, their words \u2013 and message \u2013 had a positive impact.<\/p>\n<h5>Angela Willette Knight, mother of Jack Knight, a 17-year-old with DMD<\/h5>\n<blockquote><p>\u201cThey gave us the opportunity to go and get more information. And they confirmed that what we do have is compelling. So, I think the fact that it is compelling is very huge. And we were heard, and that was part of the totality of the data and part of what went into the decision process.\u201d<\/p><\/blockquote>\n<p>&nbsp;<\/p>\n<h3><strong>Anything could happen<\/strong><\/h3>\n<p>The FDA typically follows the advice of its advisory panels. But, last year, an exception occurred when the FDA approved, for the first time, Exondys 51 (eteplirsen; Sarepta Therapeutics), a drug for children with a specific cause of DMD.<\/p>\n<p>Our team feels very good about the positive feedback that the FDA gave to the DMD community. The story will continue on October 24, 2017, when the FDA will make a final decision. At this point, anything could happen.<\/p>\n<h5>Interesting links<\/h5>\n<p><a href=\"https:\/\/seekingalpha.com\/news\/3298268-fda-ad-com-says-data-ptcs-translarna-inclusive-needed-prove-efficacy\">https:\/\/seekingalpha.com\/news\/3298268-fda-ad-com-says-data-ptcs-translarna-inclusive-needed-prove-efficacy<\/a><\/p>\n<p><a href=\"https:\/\/pharmaphorum.com\/news\/fda-reviewers-slam-ptc-dmd-drug-ahead-key-meeting\/\">https:\/\/pharmaphorum.com\/news\/fda-reviewers-slam-ptc-dmd-drug-ahead-key-meeting\/<\/a><\/p>\n<p><a href=\"http:\/\/www.xconomy.com\/new-york\/2017\/09\/28\/fda-panel-pans-ptcs-audacious-plan-to-force-vote-on-duchenne-drug\/\">http:\/\/www.xconomy.com\/new-york\/2017\/09\/28\/fda-panel-pans-ptcs-audacious-plan-to-force-vote-on-duchenne-drug\/<\/a><\/p>\n<p><a href=\"https:\/\/emflaza.com\/\" target=\"_blank\" rel=\"noopener noreferrer\">Emflaza<\/a><\/p>\n<p><a href=\"https:\/\/www.sarepta.com\/our-product\" target=\"_blank\" rel=\"noopener noreferrer\">Exondys 51 (eteplirsen; Sarepta Therapeutics)<\/a><\/p>\n<p><a href=\"http:\/\/www.ptcbio.com\/en\/pipeline\/ataluren-translarna\/\" target=\"_blank\" rel=\"noopener noreferrer\">Translarna (ataluren; PTC Therapeutics Inc.)<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>On September 28, 2017, the U.S. Food and Drug Administration (FDA) held an Advisory Committee (AdCom) meeting to discuss the new drug application for ataluren for oral suspension (PTC Therapeutics Inc.). This committee allows stakeholders to present additional data, information and views on treatment. At the end of this hearing, the AdCom voted that more [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":5537,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[12],"tags":[],"class_list":["post-5536","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.6 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Advisory Committee (AdCom) hears the voice of the DMD community<\/title>\n<meta name=\"description\" content=\"This AdCom allows experts to present additional data. 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