{"id":80339,"date":"2018-03-01T09:15:11","date_gmt":"2018-03-01T06:15:11","guid":{"rendered":"https:\/\/newsroom.su\/?p=80339"},"modified":"2018-03-01T09:15:11","modified_gmt":"2018-03-01T06:15:11","slug":"mavenclad-cladribine-tablets-receives-first-approval-in-latin-america","status":"publish","type":"post","link":"https:\/\/newsroom.su\/?p=80339","title":{"rendered":"Mavenclad (Cladribine Tablets) Receives First Approval in Latin America"},"content":{"rendered":"<div class=\"8a53641db43077f6712193da0bbeb89a\" data-index=\"1\" style=\"float: none; margin:10px 0 10px 0; text-align:center;\">\n<script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js\"><\/script>\r\n<!-- 1 newsroom -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:inline-block;width:468px;height:60px\"\r\n     data-ad-client=\"ca-pub-2753775886465733\"\r\n     data-ad-slot=\"8795226203\"><\/ins>\r\n<script>\r\n(adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<div id=\"mpuls-widget-471\"><\/div>\r\n<script language=\"javascript\" type=\"text\/javascript\">\r\n(function() {\r\nvar useSSL = 'https:' == document.location.protocol;\r\nvar mpuls = document.createElement('script');\r\nmpuls.type = 'text\/javascript'; mpuls.async = true;mpuls.charset = 'UTF-8';\r\nmpuls.src = (useSSL ? 'https:' : 'http:') + '\/\/www.mpuls.ru\/load\/471.js';\r\nvar nrvrscr = document.getElementsByTagName('script')[0];\r\nnrvrscr.parentNode.insertBefore(mpuls, nrvrscr);\r\n})();\r\n<\/script>\n<\/div>\n<p><a href=\"https:\/\/newsroom.su\/wp-content\/uploads\/2018\/02\/Mavenclad-Cladribine-Tablets-Receives-First-Approval-in-Latin-America.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"alignleft  wp-image-80360\" src=\"https:\/\/newsroom.su\/wp-content\/uploads\/2018\/02\/Mavenclad-Cladribine-Tablets-Receives-First-Approval-in-Latin-America.jpg\" alt=\"\" width=\"285\" height=\"151\" srcset=\"https:\/\/newsroom.su\/wp-content\/uploads\/2018\/02\/Mavenclad-Cladribine-Tablets-Receives-First-Approval-in-Latin-America.jpg 613w, https:\/\/newsroom.su\/wp-content\/uploads\/2018\/02\/Mavenclad-Cladribine-Tablets-Receives-First-Approval-in-Latin-America-300x159.jpg 300w\" sizes=\"auto, (max-width: 285px) 100vw, 285px\" \/><\/a>DARMSTADT, Germany, February 26, 2018\/PRNewswire-FirstCall\/ &#8212;<\/p>\n<p>Not intended for U.K.\/U.S. based media<\/p>\n<pre>\t    \r\n    - First oral short-course treatment for highly active relapsing multiple sclerosis\r\n      (RMS) now approved in Argentina\u00a0\r\n    - Mavenclad\u00a0has shown sustained clinical efficacy for up to 4 years with a maximum of 20\r\n      days of oral treatment over 2 years\r\n\r\n<\/pre>\n<p>Merck, a leading science and technology company, today announced that the Argentinian<br \/>\nAdministration of Medicines, Food and Medical Technology (ANMAT), has approved the<br \/>\nregistration of MAVENCLAD(R) (cladribine tablets) for the treatment of adult patients with<br \/>\nhighly active relapsing multiple sclerosis (MS) as defined by clinical or imaging<br \/>\nfeatures. This marks the first approval for MAVENCLAD(R) in Latin America and following<br \/>\nlocal regulatory processes, the product is expected to be available in the coming months.<\/p>\n<p>(Logo: http:\/\/mma.prnewswire.com\/media\/472778\/Merck_Logo.jpg )<\/p>\n<p>&#171;Having a new MS treatment approved in Argentina is very motivating,&#187; said Dr. Jorge<br \/>\nCorreale M.D., the Head of Neuroimmunology and Demyelinating Diseases at the Institute for<br \/>\nNeurological Research Dr. Raul Carrea. &#171;Mavenclad allows the patient&#8217;s immune system to go<br \/>\nthrough a selective immune reconstitution, similar to a reset, and the treatment mechanism<br \/>\nis simple because it does not require frequent administration or monitoring.&#187;<\/p>\n<p>MAVENCLAD(R) is the first oral short-course treatment to provide efficacy across key<br \/>\nmeasures of disease activity in patients with highly active relapsing MS, including<br \/>\ndisability progression, annualized relapse rate and magnetic resonance imaging (MRI)<br \/>\nactivity. The approval of MAVENCLAD(R) is based on more than 10,000 patient years of data<br \/>\nwith over 2,700 patients included in the clinical trial program,[1] and up to 10 years of<br \/>\nobservation in some patients. The clinical development program included data from three<br \/>\nPhase III trials, CLARITY,[2],[3] CLARITY EXTENSION[4] and ORACLE MS,[5] the Phase II<br \/>\nONWARD study;[6] and long-term follow-up data from the 8-year prospective registry,<br \/>\nPREMIERE.[7] The efficacy and safety results of these studies allowed for a full<br \/>\ncharacterization of the benefit-to-risk profile of MAVENCLAD(R).<\/p>\n<p>&#171;We are pleased the Argentinian Administration of Medicines, Food and Medical<br \/>\nTechnology has approved Mavenclad,&#187; said Rehan Verjee, Chief Marketing and Strategy<br \/>\nOfficer at the Biopharma business of Merck. &#171;Our goal is to ensure fast access to patients<br \/>\nwho may benefit from this innovative therapy and we will be working with payers on<br \/>\nobtaining reimbursement as a next step.&#187;<\/p>\n<p>MAVENCLAD(R) is a selective immune reconstitution therapy[8],[9] which simplifies<br \/>\ntreatment administration by giving patients just 2 short annual courses of tablets with a<br \/>\nmaximum of 20 days of treatment over 2 years providing a lasting treatment benefit up to 4<br \/>\nyears. MAVENCLAD(R) works by selectively targeting B &amp; T lymphocytes followed by a<br \/>\ndistinct pattern of lymphocyte reconstitution, without continuous suppression of the<br \/>\nimmune system.[10]<\/p>\n<p>In patients with high disease activity, post hoc analyses of the two-year Phase III<br \/>\nCLARITY trial[3],[4] demonstrated that MAVENCLAD(R) reduced the annualized relapse rate by<br \/>\n67% and the risk of 6-month confirmed expanded disability status scale (EDSS) progression<br \/>\nby 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION[4] study, no<br \/>\nfurther MAVENCLAD(R) treatment was required in Years 3 and 4. The comprehensive dataset<br \/>\nhas informed the posology and monitoring requirements. The most clinically relevant<br \/>\nadverse reactions were lymphopenia and herpes zoster. Lymphocyte counts must be assessed<br \/>\nbefore, and during, treatment with MAVENCLAD(R). MAVENCLAD(R) is contraindicated in<br \/>\ncertain groups including immunocompromised patients and pregnant women.<\/p>\n<p>The approval for MAVENCLAD(R) in Argentina follows marketing authorizations in the EU,<br \/>\nCanada, Australia and Israel. Merck plans additional filings for regulatory approval in<br \/>\nother countries, including the United States.<\/p>\n<p>About MAVENCLAD(R)<br \/>\nMAVENCLAD(R) (cladribine tablets) is approved in the 28 countries of the European Union<br \/>\n(EU) in addition to Norway, Liechtenstein, Iceland, Isreal and Argentina for the treatment<br \/>\nof highly active relapsing multiple sclerosis (RMS). MAVENCLAD(R) is approved in Canada<br \/>\nand Australia for the treatment of relapsing-remitting multiple sclerosis (RRMS).<br \/>\nMAVENCLAD(R) is a short-course oral therapy that selectively targets lymphocytes thought<br \/>\nto be integral to the pathological process of relapsing MS (RMS). MAVENCLAD(R) is<br \/>\ncurrently under clinical investigation and not yet approved for the treatment for any use<br \/>\nin the United States.<\/p>\n<p>The clinical development program for MAVENCLAD(R) includes:<\/p>\n<pre>\t    \r\n    - The CLARITY (Cladribine Tablets Treating MS Orally) study: a two-year Phase III\r\n      placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD(R)\r\n      as a monotherapy in patients with RRMS.\r\n    - The CLARITY extension study: a two-year Phase III placebo-controlled study following\r\n      on from the CLARITY study, designed to evaluate the safety and efficacy of MAVENCLAD(R)\r\n      over an extended administration for four years.\r\n    - The ORACLE MS (Oral Cladribine in Early MS) study: a two-year Phase III\r\n      placebo-controlled study designed to evaluate the efficacy and safety of MAVENCLAD(R)\r\n      as a monotherapy in patients at risk of developing MS (patients who have experienced a\r\n      first clinical event suggestive of MS).\r\n    - The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active\r\n      Relapsing Disease) study: a Phase II placebo-controlled study designed primarily to\r\n      evaluate the safety and tolerability of adding MAVENCLAD(R) treatment to patients with\r\n      relapsing forms of MS, who have experienced breakthrough disease while on established\r\n      interferon-beta therapy.\r\n    - PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis\r\n      Patients Who Have Participated in Cladribine Clinical Studies) study: interim\r\n      long-term follow-up data from the prospective registry, PREMIERE, to evaluate the\r\n      safety and efficacy of MAVENCLAD(R)\r\n\r\n<\/pre>\n<p>The clinical development program of MAVENCLAD(R) in MS comprises more than 10,000<br \/>\npatient years of data with over 2,700 patients included in the clinical trial program, and<br \/>\nmore than 10 years of observation in some patients.<\/p>\n<p>About Multiple Sclerosis<br \/>\nMultiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system<br \/>\nand is the most common, non-traumatic, disabling neurological disease in young adults. It<br \/>\nis estimated that approximately 2.3 million people have MS worldwide. While symptoms can<br \/>\nvary, the most common symptoms of MS include blurred vision, numbness or tingling in the<br \/>\nlimbs and problems with strength and coordination. The relapsing forms of MS are the most<br \/>\ncommon.<\/p>\n<p>All Merck Press Releases are distributed by e-mail at the same time they become<br \/>\navailable on the Merck Website. Please go to http:\/\/www.merckgroup.com\/subscribe to<br \/>\nregister online, change your selection or discontinue this service.<\/p>\n<p>About Merck<br \/>\nMerck is a leading science and technology company in healthcare, life science and<br \/>\nperformance materials. Around 50,000 employees work to further develop technologies that<br \/>\nimprove and enhance life &#8212; from biopharmaceutical therapies to treat cancer or multiple<br \/>\nsclerosis, cutting-edge systems for scientific research and production, to liquid crystals<br \/>\nfor smartphones and LCD televisions. In 2016, Merck generated sales of EUR 15.0 billion in<br \/>\n66 countries.<\/p>\n<p>Founded in 1668, Merck is the world&#8217;s oldest pharmaceutical and chemical company. The<br \/>\nfounding family remains the majority owner of the publicly listed corporate group. Merck<br \/>\nholds the global rights to the Merck name and brand. The only exceptions are the United<br \/>\nStates and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD<br \/>\nPerformance Materials.<\/p>\n<pre>\t    \r\n\r\n    1. Merck data on file \r\n    2. Giovannoni G, Comi G, Cook S et al. A Placebo-Controlled Trial of 1O Oral Cladribine\r\n     for Relapsing Multiple Sclerosis. 2010 New England Journal of Medicine 362:416-426 \r\n    3. Giovannoni G et al. Sustained disease-activity-free status in patients with\r\n     relapsing-remitting multiple sclerosis treated with cladribine tablets in the CLARITY\r\n     study: a post-hoc and subgroup analysis Lancet Neurol 2011; 10:329-337 \r\n    4. EU Clinical Trials Register. A Phase IIIb, Double-Blind, Placebo-Controlled,\r\n     Multicenter, Parallel Group, Extension Trial to Evaluate the Safety and Tolerability\r\n     of Oral Cladribine in Subjects with Relapsing-Remitting Multiple Sclerosis Who Have\r\n     Completed Trial 25643 (CLARITY). Available at\r\n     https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2007-000381-20\/results . Last\r\n     accessed August 2017 \r\n    5. Leist T, Comi G, Cree B et al. Effect of oral cladribine on time to conversion to\r\n     clinically definite multiple sclerosis in patients with a first demyelinating event\r\n     (ORACLE MS): a phase 3 randomised trial. Lancet Neurol 2014; 13: 257-67 \r\n    6. EU Clinical Trials Register. A phase II, multicenter, randomized, double-blind,\r\n     placebo-controlled, safety, tolerability and efficacy study of add-on Cladribine\r\n     tablet therapy with Rebif New Formulation in Multiple Sclerosis Subjects with Active\r\n     Disease. Available at\r\n     https:\/\/www.clinicaltrialsregister.eu\/ctr-search\/trial\/2006-003366-33\/results . Last\r\n     accessed August 2017 \r\n    7. Schreiner T, Miravalle A,. Current and Emerging Therapies for the Treatment of\r\n     Multiple Sclerosis: Focus on Cladribine. Journal of Central Nervous System Disease.\r\n     2012; 4: 1-14 \r\n    8. Giovannoni G. Personalized medicine in multiple sclerosis. 2017 Neurodegenerative\r\n     Disease Management; 7 (6s) 13-17 \r\n    9. Giovannoni G. Cladribine to Treat Relapsing Forms of Multiple Sclerosis.\r\n     Neurotherapeutics. November 2017; DOI 10.1007\/s13311-017-0573-4 \r\n    10. MAVENCLAD(TM) Product Monograph. November 2017 \r\n\r\n<\/pre>\n<p>Photo:<br \/>\nhttp:\/\/mma.prnewswire.com\/media\/472778\/Merck_Logo.jpg<\/p>\n<p>Source:<br \/>\nMerck<\/p>\n<p>Erin Beals, +1-781-681-2850<\/p>\n<div class=\"8a53641db43077f6712193da0bbeb89a\" data-index=\"1\" style=\"float: none; margin:10px 0 10px 0; text-align:center;\">\n<script async src=\"\/\/pagead2.googlesyndication.com\/pagead\/js\/adsbygoogle.js\"><\/script>\r\n<!-- 1 newsroom -->\r\n<ins class=\"adsbygoogle\"\r\n     style=\"display:inline-block;width:468px;height:60px\"\r\n     data-ad-client=\"ca-pub-2753775886465733\"\r\n     data-ad-slot=\"8795226203\"><\/ins>\r\n<script>\r\n(adsbygoogle = window.adsbygoogle || []).push({});\r\n<\/script>\r\n<div id=\"mpuls-widget-471\"><\/div>\r\n<script language=\"javascript\" type=\"text\/javascript\">\r\n(function() {\r\nvar useSSL = 'https:' == document.location.protocol;\r\nvar mpuls = document.createElement('script');\r\nmpuls.type = 'text\/javascript'; mpuls.async = true;mpuls.charset = 'UTF-8';\r\nmpuls.src = (useSSL ? 'https:' : 'http:') + '\/\/www.mpuls.ru\/load\/471.js';\r\nvar nrvrscr = document.getElementsByTagName('script')[0];\r\nnrvrscr.parentNode.insertBefore(mpuls, nrvrscr);\r\n})();\r\n<\/script>\n<\/div>\n\n<div style=\"font-size: 0px; height: 0px; line-height: 0px; margin: 0; padding: 0; clear: both;\"><\/div>","protected":false},"excerpt":{"rendered":"<p>DARMSTADT, Germany, February 26, 2018\/PRNewswire-FirstCall\/ &#8212; Not intended for U.K.\/U.S. based media &#8212; First oral short-course treatment for highly active relapsing multiple sclerosis (RMS) now approved in Argentina\u00a0 &#8212; Mavenclad\u00a0has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years Merck, a leading science&#8230;<\/p>\n","protected":false},"author":10,"featured_media":80360,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","tstyn_error":""},"categories":[3],"tags":[129],"class_list":["post-80339","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-na-e-krane","tag-meditsina"],"aioseo_notices":[],"aioseo_head":"\n\t\t<!-- All in One SEO 4.9.8 - aioseo.com -->\n\t<meta name=\"description\" content=\"Merck, a leading science and technology company, today announced that the Argentinian Administration of Medicines, Food and Medical Technology (ANMAT), has approved the registration of MAVENCLAD(R) (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. 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This marks the first approval for MAVENCLAD(R) in Latin America and following local regulatory processes, the product is expected to be available in the coming months.\" \/>\n\t\t<meta name=\"twitter:image\" content=\"https:\/\/newsroom.su\/wp-content\/uploads\/2017\/03\/logo4-2.png\" \/>\n\t\t<script type=\"application\/ld+json\" class=\"aioseo-schema\">\n\t\t\t{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"BlogPosting\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#blogposting\",\"name\":\"Mavenclad (Cladribine Tablets) Receives First Approval in Latin America | newsroom.su\",\"headline\":\"Mavenclad (Cladribine Tablets) Receives First Approval in Latin America\",\"author\":{\"@id\":\"https:\\\/\\\/newsroom.su\\\/?author=10#author\"},\"publisher\":{\"@id\":\"https:\\\/\\\/newsroom.su\\\/#organization\"},\"image\":{\"@type\":\"ImageObject\",\"url\":\"https:\\\/\\\/newsroom.su\\\/wp-content\\\/uploads\\\/2018\\\/02\\\/Mavenclad-Cladribine-Tablets-Receives-First-Approval-in-Latin-America.jpg\",\"width\":613,\"height\":325},\"datePublished\":\"2018-03-01T09:15:11+03:00\",\"dateModified\":\"2018-03-01T09:15:11+03:00\",\"inLanguage\":\"ru-RU\",\"mainEntityOfPage\":{\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#webpage\"},\"isPartOf\":{\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#webpage\"},\"articleSection\":\"\\u041d\\u0430 \\u044d\\u043a\\u0440\\u0430\\u043d\\u0435, \\u043c\\u0435\\u0434\\u0438\\u0446\\u0438\\u043d\\u0430\"},{\"@type\":\"BreadcrumbList\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#breadcrumblist\",\"itemListElement\":[{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su#listItem\",\"position\":1,\"name\":\"Home\",\"item\":\"https:\\\/\\\/newsroom.su\",\"nextItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?cat=3#listItem\",\"name\":\"\\u041d\\u0430 \\u044d\\u043a\\u0440\\u0430\\u043d\\u0435\"}},{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?cat=3#listItem\",\"position\":2,\"name\":\"\\u041d\\u0430 \\u044d\\u043a\\u0440\\u0430\\u043d\\u0435\",\"item\":\"https:\\\/\\\/newsroom.su\\\/?cat=3\",\"nextItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#listItem\",\"name\":\"Mavenclad (Cladribine Tablets) Receives First Approval in Latin America\"},\"previousItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su#listItem\",\"name\":\"Home\"}},{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#listItem\",\"position\":3,\"name\":\"Mavenclad (Cladribine Tablets) Receives First Approval in Latin America\",\"previousItem\":{\"@type\":\"ListItem\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?cat=3#listItem\",\"name\":\"\\u041d\\u0430 \\u044d\\u043a\\u0440\\u0430\\u043d\\u0435\"}}]},{\"@type\":\"Organization\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/#organization\",\"name\":\"newsroom.su\",\"description\":\"\\u041d\\u043e\\u0432\\u043e\\u0441\\u0442\\u0438 \\u043e \\u043d\\u043e\\u0432\\u043e\\u0441\\u0442\\u044f\\u0445\",\"url\":\"https:\\\/\\\/newsroom.su\\\/\",\"logo\":{\"@type\":\"ImageObject\",\"url\":\"https:\\\/\\\/newsroom.su\\\/wp-content\\\/uploads\\\/2017\\\/03\\\/logo4-2.png\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339\\\/#organizationLogo\",\"width\":288,\"height\":90},\"image\":{\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339\\\/#organizationLogo\"}},{\"@type\":\"Person\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?author=10#author\",\"url\":\"https:\\\/\\\/newsroom.su\\\/?author=10\",\"name\":\"\\u042f\\u043a\\u043e\\u0432 \\u0411\\u043e\\u0439\\u043a\\u043e\\u0432\",\"image\":{\"@type\":\"ImageObject\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#authorImage\",\"url\":\"https:\\\/\\\/secure.gravatar.com\\\/avatar\\\/9449fdee7bad3db7c477663a848f44bf9df7c8f75b8b11b7140ff198b5f895d1?s=96&d=mm&r=g\",\"width\":96,\"height\":96,\"caption\":\"\\u042f\\u043a\\u043e\\u0432 \\u0411\\u043e\\u0439\\u043a\\u043e\\u0432\"}},{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/newsroom.su\\\/?p=80339#webpage\",\"url\":\"https:\\\/\\\/newsroom.su\\\/?p=80339\",\"name\":\"Mavenclad (Cladribine Tablets) Receives First Approval in Latin America | newsroom.su\",\"description\":\"Merck, a leading science and technology company, today announced that the Argentinian Administration of Medicines, Food and Medical Technology (ANMAT), has approved the registration of MAVENCLAD(R) (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. 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