{"id":12139,"date":"2025-02-13T12:57:00","date_gmt":"2025-02-13T11:57:00","guid":{"rendered":"https:\/\/hl-dizajn.hr\/?p=12139"},"modified":"2025-09-20T12:58:55","modified_gmt":"2025-09-20T10:58:55","slug":"americka-agencija-za-hranu-i-lijekove-odobrila-evrysdi-u-obliku-tablete","status":"publish","type":"post","link":"https:\/\/hl-dizajn.hr\/en\/americka-agencija-za-hranu-i-lijekove-odobrila-evrysdi-u-obliku-tablete\/","title":{"rendered":"Ameri\u010dka agencija za hranu i lijekove odobrila Evrysdi u obliku tablete"},"content":{"rendered":"<p><em>New York, srijeda, 12. velja\u010de 2025. \u2014 Muscular Dystrophy Organization (MDA) \u2013 Ameri\u010dka Udruga za mi\u0161i\u0107nu distrofiju danas slavi odluku Ameri\u010dke agencije za hranu i lijekove (US Food and Drug Administration &#8211; FDA) o&nbsp;<strong>odobrenju lijeka risdiplama (<a href=\"https:\/\/www.evrysdi.com\/\">Evrysdi<\/a>) u obliku tablete odnosno pilule<\/strong>, \u0161to predstavlja zna\u010dajan napredak u lije\u010denju spinalne mi\u0161i\u0107ne atrofije (SMA), vode\u0107eg genetskog uzroka smrtnosti dojen\u010dadi. Priop\u0107enje za medije tvrtke Genentech mo\u017eete pro\u010ditati&nbsp;<a href=\"https:\/\/www.gene.com\/media\/press-releases\/15052\/2025-02-12\/fda-approves-genentechs-evrysdi-tablet-a\">ovdje<\/a>.<\/em><\/p>\n\n\n\n<p><strong>Ameri\u010dka Udruga za mi\u0161i\u0107nu distrofiju slavi odobrenje od strane FDA za Evrysdi u obliku tablete, pristupa\u010dniju opciju lije\u010denja za osobe sa SMA<\/strong><\/p>\n\n\n\n<p>Ova nova formulacija pru\u017ea dodatnu mogu\u0107nost lije\u010denja za djecu i odrasle osobe, \u010dine\u0107i terapiju dostupnijom i prakti\u010dnijom s obzirom da dolazi i u obliku pilule. Evrysdi, kojeg proizvodi&nbsp;<a href=\"https:\/\/www.gene.com\/\">Genentech<\/a>, tvrtka u vlasni\u0161tvu Rochea, predstavlja terapiju koja mijenja tijek bolesti, ciljaju\u0107i genetski uzrok SMA pove\u0107anjem proizvodnje funkcionalnog proteina za pre\u017eivljavanje motori\u010dkih neurona (SMN).<\/p>\n\n\n\n<p>Odobrenje lijeka u novom obliku pilule nadovezuje se na prethodne uspjehe u lije\u010denju SMA, pridru\u017euju\u0107i se postoje\u0107em oralnom teku\u0107em obliku risdiplama (Evrysdi), kao i nusinersenu (Spinraza) tvrtke Biogen i onasemnogenabeparvovecu (Zolgensma) tvrtke Novartis Gene Therapies. Nova formulacija u obliku pilule pro\u0161iruje mogu\u0107nosti lije\u010denja, omogu\u0107uju\u0107i osobama sa SMA i njihovim obiteljima lak\u0161i pristup terapiji i ve\u0107u fleksibilnost u upravljanju bole\u0161\u0107u.<\/p>\n\n\n\n<p>\u201e<em>Ameri\u010dka Udruga za mi\u0161i\u0107nu distrofiju slavi stalni napredak u lije\u010denju SMA, osiguravaju\u0107i osobama sa SMA pristup u\u010dinkovitim i prakti\u010dnim terapijama.<\/em>\u201c izjavila je Sharon Hesterlee, dr. sc., izvr\u0161na potpredsjednica i glavna istra\u017eiva\u010dka direktorica MDA. \u201e<em>Odobrenje tablete Evrysdi predstavlja jo\u0161 jednu zna\u010dajnu prekretnicu za zajednicu osoba sa SMA, pru\u017eaju\u0107i jednostavniji na\u010din primjene koji pobolj\u0161ava kvalitetu \u017eivota osoba koje \u017eive s ovom bole\u0161\u0107u.<\/em>\u201c<\/p>\n\n\n\n<p>Razvoj Evrysdija temelji se na godinama istra\u017eivanja biologije SMA koje je financirala MDA. Udruga za mi\u0161i\u0107nu distrofiju ulo\u017eila je vi\u0161e od 50 milijuna dolara u projekte povezane sa SMA i vi\u0161e od milijardu dolara u istra\u017eivanje neuromuskularnih bolesti u cjelini. Tempo razvoja lijekova nastavlja se ubrzavati, donose\u0107i novu nadu za osobe sa SMA i drugim neuromuskularnim bolestima.<\/p>\n\n\n\n<p><strong>Studija podr\u017eala odobrenje Evrysdija u obliku&nbsp;tableta<\/strong><\/p>\n\n\n\n<p>Prema priop\u0107enju tvrtke Genentech, odobrenje tablete Evrysdi temeljilo se na rezultatima studije bioekvivalencije, koja je pokazala da tableta od 5 mg, bilo da se proguta cijela ili rastopi u nekloriranoj vodi za pi\u0107e (npr. filtriranoj vodi), pru\u017ea usporedivu izlo\u017eenost risdiplamu kao i originalna oralna otopina. To zna\u010di da osobe koje uzimaju tabletu mogu o\u010dekivati istu dokazanu u\u010dinkovitost i sigurnost kao kod oralne otopine Evrysdi.<\/p>\n\n\n\n<p>Oralna otopina Evrysdi i dalje \u0107e biti dostupna za osobe koje koriste druge doze Evrysdija ili za one koji preferiraju teku\u0107i oblik lijeka.<\/p>\n\n\n\n<p>Studija je prvotno predstavljena na MDA klini\u010dko-znanstvenoj konferenciji 2024., a sa\u017eetak istra\u017eivanja mo\u017eete pogledati&nbsp;<a href=\"https:\/\/www.mdaconference.org\/abstract-library\/bioequivalence-and-food-effect-assessment-for-a-new-risdiplam-tablet-formulation-in-healthy-volunteers\/\">ovdje<\/a>.<\/p>\n\n\n\n<p><strong>O spinalnoj mi\u0161i\u0107noj atrofiji (SMA)<\/strong><\/p>\n\n\n\n<p>SMA je uzrokovana mutacijom ili nedostatkom gena survival motor neuron 1 (SMN1), \u0161to dovodi do nedostatne proizvodnje SMN proteina, gubitka motori\u010dkih neurona, slabosti mi\u0161i\u0107a i paralize. SMA se klasificira u \u010detiri tipa prema dobi pojave simptoma i te\u017eini simtoma, pri \u010demu je tip 1 najte\u017ei oblik.<\/p>\n\n\n\n<p><strong>O Evrysdiju<\/strong><\/p>\n\n\n\n<p>Evrysdi je modifikatorSMN2-splicinga dizajniran za pove\u0107anje proizvodnje funkcionalnog SMN proteina. Uvo\u0111enjem nove formulacije u obliku tablete, Evrysdi sada nudi alternativni na\u010din primjene, pobolj\u0161avaju\u0107i pridr\u017eavanje terapije i njezinu dostupnost.<\/p>\n\n\n\n<p><strong>MDA Resursni centar<\/strong><\/p>\n\n\n\n<p><a href=\"https:\/\/www.mda.org\/care\/mda-resource-center\">MDA Resursni centar<\/a>&nbsp;pru\u017ea individualnu podr\u0161ku putem telefona ili e-po\u0161te osobama i obiteljima koje tra\u017ee informacije o bolestima, resursima, aktivnostima i pristupu skrbi u Sjedinjenim Ameri\u010dkim Dr\u017eavama kroz mre\u017eu&nbsp;<a href=\"mailto:press@mdausa.org\">MDA Care Center<\/a>.<\/p>\n\n\n\n<p>Za medijske upite obratite se na&nbsp;<a href=\"mailto:press@mdausa.org\">press@mdausa.org<\/a>.<\/p>\n\n\n\n<p><strong>O ameri\u010dkoj Udruzi za mi\u0161i\u0107nu distrofiju (MDA)<\/strong><\/p>\n\n\n\n<p>Ameri\u010dka Udruga za mi\u0161i\u0107nu distrofiju (MDA) vode\u0107a je volonterska zdravstvena organizacija u Sjedinjenim Ameri\u010dkim Dr\u017eavama koja podr\u017eava osobe s mi\u0161i\u0107nom distrofijom, ALS-om i vi\u0161e od 300 drugih neuromuskularnih bolesti. Ve\u0107 75 godina MDA predvodi ubrzavanje istra\u017eivanja, unapre\u0111enje skrbi te zagovaranje podr\u0161ke i inkluzije za obitelji pogo\u0111ene neuromuskularnim bolestima.<\/p>\n\n\n\n<p><em><strong>Izvor<\/strong><\/em>:&nbsp;<a href=\"https:\/\/www.mda.org\/press-releases\/2025\/fda-approves-new-tablet-form-of-evrysdi-for-treatment-of-spinal-muscular-atrophy\">mda.org<\/a><\/p>\n\n\n\n<p><strong>SDDH vjeruje da \u0107e ovaj novi oblik primjene lijeka za osobe sa SMA ubrzo biti odobren&nbsp;i od strane Europske agencije za lijekove (EMA), a potom i od hrvatske Agencije za lijekove i medicinske proizvode (HALMED) \u010dime bi se olak\u0161ala njegova primjena i lijek postao jo\u0161 dostupniji&nbsp;za osobe sa SMA u Republici Hrvatskoj.<\/strong><\/p>","protected":false},"excerpt":{"rendered":"<p>New York, srijeda, 12. velja\u010de 2025. \u2014 Muscular Dystrophy Organization (MDA) \u2013 Ameri\u010dka Udruga za mi\u0161i\u0107nu distrofiju danas slavi odluku Ameri\u010dke agencije za hranu i lijekove (US Food and Drug Administration &#8211; FDA) o&nbsp;odobrenju lijeka risdiplama (Evrysdi) u obliku tablete odnosno pilule, \u0161to predstavlja zna\u010dajan napredak u lije\u010denju spinalne mi\u0161i\u0107ne atrofije (SMA), vode\u0107eg genetskog uzroka [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":12140,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"elementor_theme","format":"standard","meta":{"footnotes":""},"categories":[16],"tags":[68],"class_list":["post-12139","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-sddh-vijesti","tag-sustavna-podrska"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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