A Catalyst Pharmaceuticals anunciou que a Health Canada aceitou sua New Drug Submission (NDS) para AGAMREE (vamorolone) com status de revis\u00e3o priorit\u00e1ria para tratamento de distrofia muscular de Duchenne (DMD). Se aprovado, o AGAMREE se tornaria a primeira e \u00fanica terapia aprovada pela Health Canada para DMD, com potencial autoriza\u00e7\u00e3o de comercializa\u00e7\u00e3o at\u00e9 o final de 2025.<\/p>\n\n\n\n
A submiss\u00e3o segue as aprova\u00e7\u00f5es da AGAMREE nos EUA (2023) e na Uni\u00e3o Europeia (in\u00edcio de 2024). De acordo com o registro canadense de doen\u00e7as neuromusculares, mais de 800 meninos e homens jovens no Canad\u00e1 vivem com DMD, uma doen\u00e7a rara que causa fraqueza muscular devido \u00e0 falta de prote\u00edna distrofina. (O que \u00e9 Agamree?<\/a>)<\/p>\n\n\n\n O desenvolvimento do medicamento incluiu ensaios cl\u00ednicos em cinco locais canadenses, contribuindo para sua aprova\u00e7\u00e3o global. Organiza\u00e7\u00f5es de pacientes, incluindo Defeat Duchenne Canada e Muscular Dystrophy Canada, acolheram esse desenvolvimento, destacando a atual falta de tratamentos aprovados no Canad\u00e1.<\/p>","protected":false},"excerpt":{"rendered":" Catalyst Pharmaceuticals has announced that Health Canada has accepted their New Drug Submission (NDS) for AGAMREE (vamorolone) with priority review status for treating Duchenne muscular dystrophy (DMD). If approved, AGAMREE would become the first and only Health Canada-approved therapy for DMD, with potential marketing authorization by the end of 2025. The submission follows AGAMREE’s approvals […]<\/p>\n","protected":false},"author":1,"featured_media":3588,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[281],"tags":[42,171,43],"class_list":["post-3586","post","type-post","status-publish","format-standard","has-post-thumbnail","category-press-releases","tag-agamree","tag-canada","tag-vamorolone"],"subtitle":"A Health Canada concedeu ao AGAMREE uma revis\u00e3o priorit\u00e1ria e a autoriza\u00e7\u00e3o de comercializa\u00e7\u00e3o pode ser concedida antes do final de 2025.","_links":{"self":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/3586","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=3586"}],"version-history":[{"count":0,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/posts\/3586\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media\/3588"}],"wp:attachment":[{"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/media?parent=3586"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/categories?post=3586"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/dmdwarrior.com\/pt\/wp-json\/wp\/v2\/tags?post=3586"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}