\nAgen\u0163ia European\u0103 pentru Medicamente (EMA) a recomandat vineri autorizarea \u00een Uniunea European\u0103 (UE) a medicamentului Teizeild (teplizumab), primul tratament capabil s\u0103 \u00eent\u00e2rzie apari\u0163ia diabetului de tip 1, o boal\u0103 autoimun\u0103 cronic\u0103 care afecteaz\u0103 2,2 milioane de persoane \u00een Europa \u015fi care debuteaz\u0103 de obicei \u00een copil\u0103rie, scrie EFE.<\/p>\n
\nMedicamentul inovator este indicat adul\u0163ilor \u015fi copiilor cu v\u00e2rsta de 8 ani \u015fi peste care se afl\u0103 \u00een stadiul 2 al bolii, c\u00e2nd nu necesit\u0103 \u00eenc\u0103 injec\u0163ii zilnice cu insulin\u0103. \u00cen prezent, nu exist\u0103 niciun tratament aprobat pentru a \u00eent\u00e2rzia sau a preveni progresia diabetului de tip 1 .<\/p>\n
\nConform datelor evaluate de EMA, Teizeild a reu\u015fit s\u0103 \u00eent\u00e2rzie debutul fazei 3 , c\u00e2nd apar simptomele \u015fi este necesar\u0103 insulina zilnic\u0103 , cu o medie de 50 de luni, comparativ cu 25 de luni observate la pacien\u0163ii care au primit un placebo.<\/p>\n
\nSubstan\u0163a activ\u0103, teplizumab, este un anticorp care \u00eencetine\u015fte distrugerea celulelor beta pancreatice responsabile de producerea de insulin\u0103 \u015fi se administreaz\u0103 intravenos timp de 14 zile consecutive.<\/p>\n
\nComitetul \u015ftiin\u0163ific al agen\u0163iei europene, cu sediul la Amsterdam, a subliniat beneficiul clinic observat \u015fi a sus\u0163inut aprobarea acestuia \u00een ciuda efectelor secundare frecvente, inclusiv sc\u0103derea num\u0103rului de leucocite, erup\u0163ii cutanate \u015fi tulbur\u0103ri metabolice.<\/p>\n
\nDou\u0103 procente dintre pacien\u0163i au prezentat sindromul de eliberare de citokine, o reac\u0163ie grav\u0103 inclus\u0103 \u00een planul de gestionare a riscurilor.<\/p>\n
\nTeizeild a fost dezvoltat cu sprijinul programului PRIME, destinat medicamentelor inovatoare care r\u0103spund nevoilor medicale neacoperite.<\/p>\n
\nAceast\u0103 recomandare va fi transmis\u0103 acum Comisiei Europene , care este responsabil\u0103 de luarea deciziei finale privind autoriza\u0163ia de comercializare \u00een \u00eentreaga UE, iar odat\u0103 aprobat\u0103, pre\u0163ul \u015fi rambursarea vor fi negociate la nivelul fiec\u0103rui stat membru.<\/p>\n
\n <\/p>\n
\n <\/p>\n","protected":false},"excerpt":{"rendered":"
EMA a recomandat vineri autorizarea \u00een Uniunea European\u0103 (UE) a medicamentului Teizeild.<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[510],"tags":[15493,32260,12923],"class_list":["post-242265","post","type-post","status-publish","format-standard","hentry","category-actualitate","tag-diabet","tag-medicament","tag-tratament"],"_links":{"self":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/242265","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=242265"}],"version-history":[{"count":0,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=\/wp\/v2\/posts\/242265\/revisions"}],"wp:attachment":[{"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=242265"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=242265"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/bm.dev.synology.me\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=242265"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}