Evropsk\u00e1 komise (EC) schv\u00e1lila p\u0159\u00edpravek ENFLONSIA\u2122 (clesrovimab) pro prevenci onemocn\u011bn\u00ed doln\u00edch cest d\u00fdchac\u00edch zp\u016fsoben\u00fdch respira\u010dn\u00edm syncyti\u00e1ln\u00edm virem (RSV) u novorozenc\u016f a kojenc\u016f b\u011bhem jejich prvn\u00ed sez\u00f3ny RSV. ENFLONSIA je kontraindikov\u00e1na u kojenc\u016f s hypersenzitivitou na l\u00e9\u010divou l\u00e1tku nebo na kteroukoli z jej\u00edch pomocn\u00fdch l\u00e1tek. ENFLONSIA je preventivn\u00ed, dlouhodob\u011b p\u016fsob\u00edc\u00ed monoklon\u00e1ln\u00ed protil\u00e1tka (mAb) ur\u010den\u00e1 k zaji\u0161t\u011bn\u00ed p\u0159\u00edm\u00e9, rychl\u00e9 a trval\u00e9 ochrany po dobu 5 m\u011bs\u00edc\u016f, co\u017e odpov\u00edd\u00e1 typick\u00e9 sez\u00f3n\u011b RSV, s d\u00e1vkov\u00e1n\u00edm bez z\u00e1vislosti na t\u011blesn\u00e9 hmotnosti. Schv\u00e1len\u00ed EC povoluje uveden\u00ed p\u0159\u00edpravku ENFLONSIA na trh ve v\u0161ech 27 \u010dlensk\u00fdch zem\u00edch Evropsk\u00e9 unie (EU).<\/p>\n\n\n\n
Schv\u00e1len\u00ed Evropskou komis\u00ed se op\u00edr\u00e1 o v\u00fdsledky kl\u00ed\u010dov\u00e9 studie f\u00e1ze IIb\/III CLEVER (MK-1654-004; NCT04767373), kter\u00e1 hodnotila bezpe\u010dnost a \u00fa\u010dinnost jednor\u00e1zov\u00e9 d\u00e1vky p\u0159\u00edpravku ENFLONSIA podan\u00e9 p\u0159ed\u010dasn\u011b narozen\u00fdm a dono\u0161en\u00fdm kojenc\u016fm (od narozen\u00ed do 1 roku v\u011bku), a o p\u0159edb\u011b\u017en\u00e9 \u00fadaje z 1. sez\u00f3ny RSV ve studii III. f\u00e1ze SMART (MK-1654-007; NCT04938830), je\u017e posuzovala bezpe\u010dnost, \u00fa\u010dinnost a farmakokinetiku p\u0159\u00edpravku ENFLONSIA ve srovn\u00e1n\u00ed s palivizumabem u kojenc\u016f se zv\u00fd\u0161en\u00fdm rizikem z\u00e1va\u017en\u00e9ho onemocn\u011bn\u00ed RSV. Klinick\u00e1 data ze studi\u00ed CLEVER a SMART byla zve\u0159ejn\u011bna v \u010dasopise New England Journal of Medicine v z\u00e1\u0159\u00ed 2025.<\/p>\n","protected":false},"excerpt":{"rendered":"
Evropsk\u00e1 komise (EC) schv\u00e1lila p\u0159\u00edpravek ENFLONSIA\u2122 (clesrovimab) pro prevenci onemocn\u011bn\u00ed doln\u00edch cest d\u00fdchac\u00edch zp\u016fsoben\u00fdch respira\u010dn\u00edm syncyti\u00e1ln\u00edm virem (RSV) […]<\/p>\n","protected":false},"author":4,"featured_media":3898,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":true,"kia_subtitle":""},"categories":[1],"tags":[],"class_list":["post-7336","post","type-post","status-publish","has-post-thumbnail","hentry","category-nezarazene"],"acf":[],"lang":"cs","translations":{"cs":7336},"pll_sync_post":[],"_links":{"self":[{"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/posts\/7336","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/comments?post=7336"}],"version-history":[{"count":0,"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/posts\/7336\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/media\/3898"}],"wp:attachment":[{"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/media?parent=7336"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/categories?post=7336"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.pediatrics.cz\/api\/wp\/v2\/tags?post=7336"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}