{"id":16018,"date":"2017-08-31T17:25:13","date_gmt":"2017-08-31T20:25:13","guid":{"rendered":"https:\/\/www.tiabeth.com.br\/?p=16018"},"modified":"2017-08-31T23:52:10","modified_gmt":"2017-09-01T02:52:10","slug":"fda-aprova-lusduna-nexvue-insulina-basal-biosimilar-da-merck","status":"publish","type":"post","link":"https:\/\/www.tiabeth.com.br\/index.php\/2017\/08\/31\/fda-aprova-lusduna-nexvue-insulina-basal-biosimilar-da-merck\/","title":{"rendered":"FDA aprova LUSDUNA Nexvue, Insulina Basal &#8220;Biosimilar&#8221; da Merck"},"content":{"rendered":"<p><a href=\"https:\/\/www.tiabeth.com.br\/wp-content\/uploads\/2017\/08\/merck1.jpg\"><img loading=\"lazy\" class=\"aligncenter size-full wp-image-16019\" src=\"https:\/\/www.tiabeth.com.br\/wp-content\/uploads\/2017\/08\/merck1.jpg\" alt=\"\" width=\"1000\" height=\"650\" srcset=\"https:\/\/www.tiabeth.com.br\/wp-content\/uploads\/2017\/08\/merck1.jpg 1000w, https:\/\/www.tiabeth.com.br\/wp-content\/uploads\/2017\/08\/merck1-300x195.jpg 300w, https:\/\/www.tiabeth.com.br\/wp-content\/uploads\/2017\/08\/merck1-768x499.jpg 768w, https:\/\/www.tiabeth.com.br\/wp-content\/uploads\/2017\/08\/merck1-765x496.jpg 765w\" sizes=\"(max-width: 1000px) 100vw, 1000px\" \/><\/a><\/p>\n<p>Em 20 de julho \u00faltimo, o FDA concedeu aprova\u00e7\u00e3o provis\u00f3ria para LUSDUNA Nexvue da Merck, uma inje\u00e7\u00e3o de insulina basal &#8220;biossimilar&#8221; para pessoas com diabetes tipo 1 e tipo 2.\u00a0O atraso na obten\u00e7\u00e3o da aprova\u00e7\u00e3o completa vem devido a um processo de viola\u00e7\u00e3o de patente em curso arquivado pela Sanofi que ter\u00e1 que ser resolvido antes que LUSDUNA Nexvue possa estar dispon\u00edvel.\u00a0N\u00e3o est\u00e1 claro quando isso acontecer\u00e1.<\/p>\n<p>Por ser uma insulina glargina &#8220;biosimilar&#8221; significa que LUSDUNA Nexvue \u00e9 modelada conforme a\u00a0<a href=\"https:\/\/diatribe.org\/injected-insulin\" target=\"_blank\" rel=\"noopener\">insulina basal<\/a>\u00a0popular\u00a0Lantus (leia mais sobre as insulinas biosimilares\u00a0<a href=\"https:\/\/diatribe.org\/long-acting-basaglar-and-new-era-biosimilar-insulin\" target=\"_blank\" rel=\"noopener\">aqui)<\/a>, semelhante a\u00a0<a href=\"https:\/\/www.basaglar.com\/en\/\" target=\"_blank\" rel=\"noopener\">Basaglar<\/a>\u00a0j\u00e1 lan\u00e7ada.<\/p>\n<p>Em geral, os medicamentos &#8220;biosimilares&#8221; t\u00eam pre\u00e7os inferiores ao produto original;\u00a0Basaglar, por exemplo, \u00e9 15% mais barato do que a Lantus.\u00a0Muitos esperam que a LUSDUNA Nexvue siga uma tend\u00eancia similar.\u00a0Pagar menos n\u00e3o significa necessariamente qualidade inferior, uma vez que LUSDUNA Nexvue promete funcionar de forma semelhante a Lantus.<\/p>\n<p>Em um estudo com mais de 500 pessoas com diabetes tipo 1, LUSDUNA Nexvue mostrou resultados semelhantes \u00e0 Lantus na capacidade de baixar o A1c, nos requisitos de dose e seguran\u00e7a e na tolerabilidade globais.\u00a0Um estudo separado com mais de 500 pessoas com diabetes tipo 2 apresentou requisitos de dose de insulina, seguran\u00e7a, tolerabilidade e redu\u00e7\u00e3o de n\u00edveis de A1c entre Lantus e LUSDUNA Nexvue.<\/p>\n<p>O processo de viola\u00e7\u00e3o de patente arquivado pela Sanofi em setembro de 2016 encerrou automaticamente a decis\u00e3o de aprova\u00e7\u00e3o final.\u00a0A LUSDUNA Nexvue n\u00e3o ser\u00e1 eleg\u00edvel para aprova\u00e7\u00e3o completa pela FDA at\u00e9 a Merck e Sanofi chegarem a um acordo, que um tribunal decide a favor da Merck, ou 30 meses ap\u00f3s o encerramento do processo (que ser\u00e1 mar\u00e7o de 2019).<\/p>\n<p>A insulina basal &#8220;biosimilar&#8221; da Lilly \/ BI, Basaglar, sofreu um bloqueio legal semelhante (leia mais sobre isso\u00a0<a href=\"https:\/\/diatribe.org\/fda-approves-new-insulin-glargine-basaglar-first-biosimilar-insulin-us\" target=\"_blank\" rel=\"noopener\">aqui<\/a>), mas eventualmente obteve aprova\u00e7\u00e3o completa do FDA.<\/p>\n<p>Uma vez totalmente aprovada, a insulina basal &#8220;biossimilar&#8221; ser\u00e1 indicada para diabetes tipo 1 e tipo 2.\u00a0Historicamente, a Merck n\u00e3o tem presen\u00e7a no mercado de insulina, ent\u00e3o a LUSDUNA Nexvue significa uma nova incurs\u00e3o para a empresa farmac\u00eautica.<\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/diatribe.org\/fda-tentatively-approves-basal-insulin-lusduna-nexvue\" target=\"_blank\" rel=\"noopener\">https:\/\/diatribe.org\/<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Em 20 de julho \u00faltimo, o FDA concedeu aprova\u00e7\u00e3o provis\u00f3ria para LUSDUNA Nexvue da Merck, uma inje\u00e7\u00e3o de insulina basal &#8220;biossimilar&#8221; para pessoas com diabetes tipo 1 e tipo 2.\u00a0O atraso na obten\u00e7\u00e3o da aprova\u00e7\u00e3o completa vem devido a um processo de viola\u00e7\u00e3o de patente em curso arquivado pela Sanofi que ter\u00e1 que ser resolvido [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":16019,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":[],"categories":[19,196],"tags":[4178,3385,28,45,1808,1206,4235,1685,4236],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v19.3 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\r\n<title>FDA aprova LUSDUNA Nexvue, Insulina Basal &quot;Biosimilar&quot; da Merck - TiaBeth.com<\/title>\r\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\r\n<link rel=\"canonical\" href=\"https:\/\/www.tiabeth.com.br\/index.php\/2017\/08\/31\/fda-aprova-lusduna-nexvue-insulina-basal-biosimilar-da-merck\/\" \/>\r\n<meta property=\"og:locale\" content=\"pt_BR\" \/>\r\n<meta property=\"og:type\" content=\"article\" \/>\r\n<meta property=\"og:title\" content=\"FDA aprova LUSDUNA Nexvue, Insulina Basal &quot;Biosimilar&quot; da Merck - TiaBeth.com\" 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