{"id":921,"date":"2013-03-09T16:06:54","date_gmt":"2013-03-09T14:06:54","guid":{"rendered":"http:\/\/slanedeti.sk\/cms\/orphan-statut-pre-aerovanc-2\/201303"},"modified":"2014-01-01T12:18:13","modified_gmt":"2014-01-01T11:18:13","slug":"orphan-statut-pre-aerovanc-2","status":"publish","type":"post","link":"https:\/\/slanedeti.sk\/cms\/orphan-statut-pre-aerovanc-2\/921","title":{"rendered":"Orphan \u0161tat\u00fat pre AeroVanc"},"content":{"rendered":"

Spolo\u010dnos\u0165 Savara Pharmaceuticals ozn\u00e1nila, \u017ee americk\u00fd \u00darad pre potraviny a lieky (Food and Drug Administration, FDA) udelil orphan \u0161tat\u00fat pre jej liek AeroVanc. AeroVanc je liek v \u0161t\u00e1diu klinick\u00e9ho v\u00fdvoja, pri\u010dom v s\u00fa\u010dastnosti sa pripravuje f\u00e1za IIa klinick\u00e9ho sk\u00fa\u0161ania.<\/p>\n

Pod\u013ea vyhl\u00e1senia spolo\u010dnosti f\u00e1za I preuk\u00e1zala bezpe\u010dnos\u0165 lieku a vynikaj\u00faci farmakokinetick\u00fd profil. AeroVanc obsahuje antibiotikum vankomyc\u00edn a je ur\u010den\u00fd na inhala\u010dn\u00e9 podanie u CF pacientov trpiacich na MRSA (metycil\u00edn rezistentn\u00fd Staphylococcus aureus) infekciu.<\/p>\n

Gener\u00e1lny riadite\u013ea Savary, Robert Neville vyjadril n\u00e1dej, \u017ee liek \u201cprinesieme podobn\u00fd \u00fa\u017eitok pre MRSA infikovan\u00fdch pacientov ako priniesol tobramyc\u00edn pri infekci\u00e1ch Pseudomonas aeruginosa. Odozva z CF komunity je ve\u013emi povzbudzuj\u00faca a podobne lek\u00e1ri sa vyjadruj\u00fa o AeroVanc ako\u00a0 o ‚TOBI pre MRSA‘ \u201c.<\/p>\n

V\u00fdhodou AeroVancu by malo by\u0165 jednoduch\u00e9 inhala\u010dn\u00e9 podanie, ke\u010f\u017ee v s\u00fa\u010dasnosti je vankomyc\u00edn aplikovan\u00fd intraven\u00f3zne, \u010do prin\u00e1\u0161a ur\u010dit\u00e9 probl\u00e9my. Pri intraven\u00f3znej\u00a0 aplik\u00e1cii prenik\u00e1 na miesto \u00fa\u010dinku do p\u013e\u00fac iba mal\u00e1 frakcia lie\u010diva. AeroVanc by teda mohol prinies\u0165 okrem jednoduch\u0161ej aplik\u00e1cie, vy\u0161\u0161iu \u00fa\u010dinnos\u0165 ke\u010f\u017ee lie\u010divo sa lep\u0161ie distribuuje do p\u013e\u00fac a s\u00fa miernej\u0161ie ne\u017eiad\u00face \u00fa\u010dinky v porovnan\u00ed s intraven\u00f3zne aplikovan\u00fdm vankomyc\u00ednom.<\/p>\n

\"201303091613_aerovanc\"<\/div>\n

Orphan \u0161tat\u00fat je administrat\u00edvne opatrenie vypl\u00fdvaj\u00face z americk\u00e9ho z\u00e1kona o orphan liekoch (\u201cliekoch sirot\u00e1ch\u201c), \u010di\u017ee liekov ktor\u00e9 s\u00fa ur\u010den\u00e9 na lie\u010dbu vz\u00e1cnych ochoren\u00ed. Cie\u013eom \u0161tat\u00fatu je podpori\u0165 v\u00fdvoj tak\u00fdchto liekov, ke\u010f\u017ee s\u00fa na trhu vzh\u013eadom na ni\u017e\u0161\u00ed po\u010det pacientov znev\u00fdhodnen\u00e9. K orphan \u0161tat\u00fatu sa via\u017eu ur\u010dit\u00e9 v\u00fdhody ako napr\u00edklad \u00fa\u013eavy na poplatkoch za schv\u00e1lenie uvedenia na trh, alebo dodato\u010dn\u00e9 z\u00e1ruky trhovej exkluzivity.<\/p>\n","protected":false},"excerpt":{"rendered":"

Spoločnosť Savara Pharmaceuticals oznánila, že americký Úrad pre potraviny a lieky (Food and Drug Administration, FDA) udelil orphan štatút pre jej liek AeroVanc. AeroVanc je liek v štádiu klinického vývoja, pričom v súčastnosti sa pripravuje fáza IIa klinického skúšania. Podľa … Continued<\/a><\/p>\n","protected":false},"author":7,"featured_media":1093,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"kt_blocks_editor_width":"","footnotes":""},"categories":[3],"tags":[232,210],"class_list":["post-921","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-lieky-a-liecba","tag-aerovanc","tag-lieky"],"yoast_head":"\nOrphan \u0161tat\u00fat pre AeroVanc - Slan\u00e9 deti<\/title>\n<meta name=\"description\" content=\"AeroVanc je liek v \u0161t\u00e1diu klinick\u00e9ho v\u00fdvoja, pri\u010dom v s\u00fa\u010dastnosti sa pripravuje f\u00e1za IIa klinick\u00e9ho sk\u00fa\u0161ania.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/slanedeti.sk\/cms\/orphan-statut-pre-aerovanc-2\/921\" \/>\n<meta property=\"og:locale\" content=\"sk_SK\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Orphan \u0161tat\u00fat pre AeroVanc - 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