{"id":3736,"date":"2015-03-10T17:58:03","date_gmt":"2015-03-10T17:58:03","guid":{"rendered":"https:\/\/jurmed.ro\/medici\/?p=3736"},"modified":"2015-04-01T12:05:51","modified_gmt":"2015-04-01T12:05:51","slug":"sanofi-obtine-aprobarea-fda-pentru-toujeo","status":"publish","type":"post","link":"https:\/\/jurmed.ro\/medici\/sanofi-obtine-aprobarea-fda-pentru-toujeo\/","title":{"rendered":"Sanofi ob\u0163ine aprobarea FDA pentru Toujeo\u00ae"},"content":{"rendered":"<p style=\"text-align: justify\"><strong><a href=\"http:\/\/www.sanofi.com\/\">Sanofi<\/a> <\/strong>a anun\u0163at recent c\u0103 Administra\u0163ia pentru Alimente \u015fi Medicamente din SUA (FDA) a autorizat medicamentul Toujeo<sup>\u00ae<\/sup> (insulin\u0103 glargin [de origine ADNr] injectabil\u0103, 300 U\/ml), o insulin\u0103 bazal\u0103 cu ac\u0163iune de lung\u0103 durat\u0103, care se administreaz\u0103 o dat\u0103 pe zi \u015fi care contribuie la \u00eembun\u0103t\u0103\u0163irea controlului glicemiei la pacien\u0163ii cu diabet zaharat de tip 1 sau 2. Se preconizeaz\u0103 c\u0103 Toujeo<sup>\u00ae <\/sup>va fi disponibil \u00een SUA la \u00eenceputul celui de-al doilea trimestru al anului 2015.<\/p>\n<p style=\"text-align: justify\">\u00a0<em>\u201cSanofi se m\u00e2ndre\u015fte cu portofoliul s\u0103u de tradi\u0163ie \u00eendelungat\u0103 \u00een diabet \u015fi \u00een tratamentul cu insulin\u0103, care include Lantus<\/em><em><sup>\u00ae<\/sup><\/em><em>, medicamentul care \u00eei ajut\u0103 pe pacien\u0163i s\u0103-\u015fi gestioneze diabetul de mai bine de un deceniu. Prin ob\u0163inerea autoriza\u0163iei FDA pentru Toujeo, Sanofi \u00ee\u015fi consolideaz\u0103 mo\u015ftenirea solid\u0103 \u015fi a\u015fteapt\u0103 cu ner\u0103bdare s\u0103 le ofere <\/em><a href=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2015\/03\/Sanofi-logo.jpg\"><img loading=\"lazy\" decoding=\"async\" class=\"  wp-image-3737 alignleft\" src=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2015\/03\/Sanofi-logo-300x203.jpg\" alt=\"Sanofi logo\" width=\"146\" height=\"99\" srcset=\"https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2015\/03\/Sanofi-logo-300x203.jpg 300w, https:\/\/jurmed.ro\/medici\/wp-content\/uploads\/sites\/2\/2015\/03\/Sanofi-logo.jpg 301w\" sizes=\"auto, (max-width: 146px) 100vw, 146px\" \/><\/a><em>persoanelor cu diabet aceast\u0103 nou\u0103 op\u0163iune de tratament\u201d, <\/em>a declarat Pierre Chancel<em>, <\/em>Senior Vice-Pre\u015fedinte al Diviziei Globale Diabet a Sanofi.<\/p>\n<p style=\"text-align: justify\">\u00a0FDA a acordat autoriza\u0163ia pentru Toujeo<em><sup>\u00ae<\/sup><\/em> pe baza analizei rezultatelor ob\u0163inute prin programul de studii clinice EDITION, care include mai multe studii interna\u0163ionale de faz\u0103 III, care au evaluat eficacitatea \u015fi siguran\u0163a Toujeo, comparativ cu Lantus, la peste 3500 de adul\u0163i cu diabet zaharat de tip 1 sau 2. \u00cen cadrul programului clinic care a dus la ob\u0163inerea autoriz\u0103rii, Toujeo<sup>\u00ae<\/sup>, administrat o dat\u0103 pe zi, a fost comparat cu Lantus administrat o dat\u0103 pe zi (insulin\u0103 glargin [de origine ADNr] injectabil\u0103, 100 U\/ml) \u00een cadrul unor studii deschise, randomizate, cu control activ, pe grupuri paralele, \u201etreat to target\u201d (tratament p\u00e2n\u0103 la atingerea \u0163intei terapeutice), cu durata de p\u00e2n\u0103 la 26 de s\u0103pt\u0103m\u00e2ni, cu extindere cu \u00eenc\u0103 6 luni pentru evaluarea siguran\u0163ei.<\/p>\n<p style=\"text-align: justify\">\u00a0<em>\u201cAproximativ 50% din persoanele cu diabet nu reu\u015fesc s\u0103 \u00ee\u015fi controleze boala\u201d, <\/em>a declarat John Anderson, medic de medicin\u0103 intern\u0103 \u015fi specialist \u00een diabet la Frist Clinic of Nashville (Tennessee) \u015fi fostul Pre\u015fedinte al Asocia\u0163iei Americane de Diabet<em>. \u201e\u00cen pofida eficacit\u0103\u0163ii dovedite a insulinei, ob\u0163inerea unei titr\u0103ri eficiente \u015fi men\u0163inerea dozelor corecte pot reprezenta o provocare pentru pacien\u0163i, dar \u015fi pentru medici, din cauza posibilei apari\u0163ii a hipoglicemiei. Toujeo ofer\u0103 o nou\u0103 op\u0163iune care \u00eei poate ajuta pe pacien\u0163i s\u0103 \u00ee\u015fi gestioneze mai bine diabetul.\u201d <\/em><\/p>\n<p style=\"text-align: justify\">\u00a0\u00cen toate studiile programului EDITION, s-a atins cu succes obiectivul primar, demonstr\u00e2ndu-se un control similar al glicemiei cu Toujeo, comparativ cu Lantus<em><sup>\u00ae<\/sup><\/em><sup>1,2<\/sup>. Cele mai frecvente reac\u0163ii adverse raportate \u00een cazul utiliz\u0103rii Toujeo<em><sup>\u00ae<\/sup><\/em> (excluz\u00e2nd episoadele de hipoglicemie) au inclus rinofaringita (12,8% din pacien\u0163ii cu diabet zaharat de tip 1 \u015fi 7,1% din pacien\u0163ii cu diabet de tip 2) \u015fi infec\u0163iile c\u0103ilor respiratorii superioare (9,5% din pacien\u0163ii cu diabet zaharat de tip 1 \u015fi 5,7% din cei cu diabet de tip 2).<\/p>\n<p style=\"text-align: justify\">\u00a0Datele farmacocinetice\/farmacodinamice pentru Toujeo<em><sup>\u00ae<\/sup><\/em>, precum \u015fi frecven\u0163a hipoglicemiilor severe \u015fi simptomatice documentate sunt men\u0163ionate \u00een informa\u0163iile despre medicament.<\/p>\n<p style=\"text-align: justify\">\u00a0Toujeo<em><sup>\u00ae<\/sup><\/em> va fi disponibil sub form\u0103 de stilou injector preumplut jetabil Toujeo<em><sup>\u00ae<\/sup><\/em> SoloSTAR<em><sup>\u00ae<\/sup><\/em>, care con\u0163ine 450 de unit\u0103\u0163i Toujeo<em><sup>\u00ae<\/sup><\/em> \u015fi necesit\u0103 o treime din volumul injectabil pentru a livra acela\u015fi num\u0103r de unit\u0103\u0163i de insulin\u0103 ca Lantus<em><sup>\u00ae<\/sup><\/em> SoloSTAR<em><sup>\u00ae<\/sup><\/em>. O doz\u0103 unic\u0103 de maxim 80 U satisface nevoile marii majorit\u0103\u0163i a pacien\u0163ilor trata\u0163i cu insulin\u0103 bazal\u0103 din Statele Unite, care au nevoie de 80 de unit\u0103\u0163i, sau mai pu\u0163in, \u00een fiecare zi. Cereri de autorizare de punere pe pia\u0163\u0103 a medicamentului Toujeo<em><sup>\u00ae<\/sup><\/em> sunt \u00een curs de examinare de c\u0103tre Agen\u0163ia European\u0103 a Medicamentului (EMA) \u015fi alte autorit\u0103\u0163i de s\u0103n\u0103tate din lume.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Sanofi a anun\u0163at recent c\u0103 Administra\u0163ia pentru Alimente \u015fi Medicamente din SUA (FDA) a autorizat medicamentul Toujeo\u00ae (insulin\u0103 glargin [de origine ADNr] injectabil\u0103, 300 U\/ml), o insulin\u0103 bazal\u0103 cu ac\u0163iune [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":3944,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_exactmetrics_skip_tracking":false,"_exactmetrics_sitenote_active":false,"_exactmetrics_sitenote_note":"","_exactmetrics_sitenote_category":0,"footnotes":""},"categories":[1],"tags":[86,87],"class_list":["post-3736","post","type-post","status-publish","format-standard","has-post-thumbnail","category-stiri-noutati","tag-sanofi","tag-toujeo"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.0 - 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