{"id":5475,"date":"2026-01-15T10:00:01","date_gmt":"2026-01-15T07:00:01","guid":{"rendered":"https:\/\/dmdwarrior.com\/?p=5475"},"modified":"2026-01-15T10:00:03","modified_gmt":"2026-01-15T07:00:03","slug":"agamree-vamorolone-has-been-approved-in-switzerland-by-swissmedic","status":"publish","type":"post","link":"https:\/\/dmdwarrior.com\/pt\/agamree-vamorolone-has-been-approved-in-switzerland-by-swissmedic\/","title":{"rendered":"AGAMREE (Vamorolone) foi aprovado na Su\u00ed\u00e7a pela Swissmedic."},"content":{"rendered":"<p class=\"wp-block-paragraph\">A Santhera Pharmaceuticals anuncia que a Ag\u00eancia Su\u00ed\u00e7a de Produtos Terap\u00eauticos (Swissmedic) aprovou o AGAMREE (vamorolona) para o tratamento da distrofia muscular de Duchenne (DMD) em pacientes com quatro anos de idade ou mais. <strong>Saber mais:<\/strong> <a href=\"https:\/\/dmdwarrior.com\/pt\/what-is-agamree-vamorolone-what-is-agamree-used-for\/\" target=\"_blank\" data-type=\"post\" data-id=\"2333\" rel=\"noreferrer noopener\">O que \u00e9 AGAMREE (Vamorolone)?<\/a><\/p>\n\n\n\n<p class=\"wp-block-paragraph\">Dario Eklund, CEO da Santhera, comentou: \u201cComo uma empresa orgulhosamente sediada na Su\u00ed\u00e7a, obter a aprova\u00e7\u00e3o da Swissmedic representa uma conquista importante e marca nossa s\u00e9tima aprova\u00e7\u00e3o de comercializa\u00e7\u00e3o global. <strong>Prevemos lan\u00e7ar o AGAMREE na Su\u00ed\u00e7a ainda em 2026, a fim de garantir o acesso oportuno a esta importante terapia para pacientes com DMD no pa\u00eds.<\/strong>\u201d<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">A aprova\u00e7\u00e3o do AGAMREE pela Swissmedic baseou-se nos dados do estudo pivotal de Fase 2b VISION-DMD e nos resultados da avalia\u00e7\u00e3o da Ag\u00eancia Europeia de Medicamentos. <strong>Ap\u00f3s a aprova\u00e7\u00e3o, a empresa obteve um per\u00edodo de exclusividade de 15 anos ao abrigo do estatuto de medicamento \u00f3rf\u00e3o su\u00ed\u00e7o.<\/strong> A Santhera mant\u00e9m os direitos exclusivos de distribui\u00e7\u00e3o do AGAMREE na Su\u00ed\u00e7a e prev\u00ea o lan\u00e7amento comercial no segundo semestre de 2026, ap\u00f3s a conclus\u00e3o dos procedimentos nacionais de precifica\u00e7\u00e3o e reembolso. <strong>Na Su\u00ed\u00e7a, existem mais de 200 pessoas afetadas pela DMD, com poucas op\u00e7\u00f5es de tratamento dispon\u00edveis.<\/strong><\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ler mais<\/strong>:&nbsp;<a href=\"https:\/\/dmdwarrior.com\/pt\/dmd-therapies\/\" target=\"_blank\" rel=\"noreferrer noopener\">Ensaios cl\u00ednicos para distrofia muscular de Duchenne (lista de todas as pesquisas)<\/a><\/p>","protected":false},"excerpt":{"rendered":"<p>Santhera Pharmaceuticals announces that the Swiss Agency for Therapeutic Products (Swissmedic), has approved AGAMREE (vamorolone) for the treatment of Duchenne muscular dystrophy (DMD) in patients four years of age and older. Learn More: What is AGAMREE (Vamorolone)? Dario Eklund, Chief Executive Officer of Santhera, commented: \u201cAs a proudly Switzerland-based business, securing Swissmedic approval represents an [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":5477,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[42,41,477,476,43],"class_list":["post-5475","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-agamree","tag-santhera","tag-swissmedic","tag-switzerland","tag-vamorolone"],"_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/5475","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/comments?post=5475"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/5475\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/5477"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=5475"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=5475"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=5475"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}