Se estimeaz\u0103 c\u0103 prin extinderea accesului la Veklury se va putea r\u0103spunde \u00een timp real cererii \u0219i se vor acoperi stocurile necesare estimate pentru luna octombrie<\/li>\n<\/ul>\nGilead Sciences \u0219i Comisia European\u0103 au semnat ast\u0103zi un acord comun de achizi\u021bie (ACA), care va permite accesul rapid \u0219i echitabil la Veklury\u00ae (remdesivir), prima terapie antiviral\u0103 a c\u0103rei eficien\u021b\u0103 a fost dovedit\u0103 \u00een tratarea COVID\u201319 pe teritoriul Uniunii Europene (UE). Acordul permite \u021b\u0103rilor din UE, Spa\u021biul Economic European (SEE) \u0219i Marea Britanie s\u0103 achizi\u021bioneze Veklury, cu supervizarea Comisiei Europene, at\u00e2t pentru necesit\u0103\u021bile \u00een timp real, c\u00e2t \u0219i pentru asigurarea stocurilor necesare. Totodat\u0103, el permite realizarea acestor achizi\u021bii pe parcursul urm\u0103toarelor \u0219ase luni \u0219i include op\u021biunea de a fi extins. \u00ceN UE, SEE \u0219i UK, Veklury este indicat pentru tratarea pacien\u021bilor adul\u021bi \u0219i adolescen\u021bi infecta\u021bi cu COVID\u201319 care sufer\u0103 de pneumonie \u0219i au nevoie de oxigen suplimentar.<\/p>\n
ACA \u00eenlocuie\u0219te Instrumentul de Asisten\u021b\u0103 pentru Situa\u021bii de Urgen\u021b\u0103 (ESI) care a permis Comisiei Europene (CE) s\u0103 achizi\u021bioneze Veklury pentru Statele Membre UE, inclusiv UK, \u00een intervalul august \u2013 octombrie 2020. Pentru a r\u0103spunde crizei actuale de s\u0103n\u0103tate provocate de noul coronavirus, at\u00e2t ESI, c\u00e2t \u0219i ACA \u00eenlocuiesc temporar necesitatea declan\u0219\u0103rii procedurilor de rambursare de la \u021bar\u0103 la \u021bar\u0103 care urmeaz\u0103, de obicei, ob\u021binerii autoriza\u021biei de introducere pe pia\u021b\u0103. Gilead va onora comenzile \u00eencep\u00e2nd cu data de 12 octombrie 2020.<\/p>\n
Comisia European\u0103 a acordat o autoriza\u021bie condi\u021bionat\u0103 de introducere pe pia\u021b\u0103 a Veklury pe 3 iulie 2020, pe baza datelor din studiul aleatoriu, dublu orb, controlat cu placebo ACTT-1, care a demonstrat eficacitatea \u0219i siguran\u021ba clinic\u0103 a Veklury \u00een tratarea pacien\u021bilor infecta\u021bi cu COVID-19 care sufer\u0103 de pneumonie \u0219i au nevoie de oxigen suplimentar. Autoriza\u021bia a fost sus\u021binut\u0103, de asemenea, de date din alte dou\u0103 studii clinice randomizate care demonstreaz\u0103 eficacitatea \u0219i siguran\u021ba Veklury \u00een protocoale de tratament care dureaz\u0103 5 \u0219i 10 zile. Suplimentarea aprovizion\u0103rii cu Veklury va extinde accesul la tratament a pacien\u021bilor infecta\u021bi cu noul coronavirus, oferindu-le posibilitatea de a-\u0219i reveni mai rapid \u0219i, \u00een consecin\u021b\u0103, de a reduce durata de spitalizare \u0219i nevoia de utilizare a resurselor de asisten\u021b\u0103 medical\u0103<\/p>\n
Se estimeaz\u0103 c\u0103 cererea global\u0103 pentru tratament s\u0103 fie acoperit\u0103 p\u00e2n\u0103 la finalul acestei luni, permi\u021b\u00e2nd achizi\u021bionarea de Veklury at\u00e2t pentru tratarea pacien\u021bilor, c\u00e2t \u0219i pentru refacerea stocului na\u021bional necesar pentru a r\u0103spunde cre\u0219terilor actuale \u0219i viitoare a cazurilor de infect\u0103ri cu COVID\u201319. Cre\u0219terea semnificativ\u0103 a stocurilor de Veklury este rezultatul unor investi\u021bii timpurii realizate de Gilead pentru a cre\u0219te capacitatea intern\u0103 de produc\u021bie, pentru a extinde re\u021beaua de produc\u021bie prin contracte externe \u0219i pentru a scurta timpul de produc\u021bie prin \u00eembun\u0103t\u0103\u021birea \u00eentregului proces de manufacturare. Peste 40 de unit\u0103\u021bi de produc\u021bie contractuale, inclusiv peste 10 situri partenere din Europa, sus\u021bin produc\u021bia \u0219i aprovizionarea cu Veklury pentru pacien\u021bi \u0219i persoanele aflate \u00een studii clinice din \u00eentreaga lume. Prin aceste eforturi, Gilead a ajuns la capacitatea de a produce mai mult de dou\u0103 milioane de cursuri de tratament Veklury \u00een acest an, cresc\u00e2nd capacitatea de aprovizionare de peste 400 de ori fa\u021b\u0103 de nivelul din ianuarie 2020. Compania este preg\u0103tit\u0103 s\u0103 produc\u0103 mai multe milioane de cursuri de tratament \u00een 2021, dac\u0103 va fi necesar.<\/p>\n
Despre Veklury (remdesivir)<\/strong><\/p>\nVeklury (remdesivir) este un analog nucleotidic dezvoltat de Gilead, rezultat \u00een urma a peste 10 ani de cercetare ai companiei \u00een domeniul antiviralelor. Veklury a dovedit o acoperire antiviral\u0103 cu spectru larg at\u00e2t \u00een vitro, c\u00e2t \u0219i in vivo, la animale, \u00eempotriva agen\u021bilor patogeni virali emergen\u021bi multipli, inclusiv Ebola, SARS, Marburg, MERS \u0219i SARS-CoV-2, virusul care cauzeaz\u0103 COVID-19. Date din trei studii clinice randomizate, \u00een care au fost inclu\u0219i pacien\u021bi spitaliza\u021bi \u00een urma infect\u0103rii cu COVID-19, au demonstrat \u00een mod substan\u021bial beneficiile clinice ale tratamentului cu Veklury. \u00cen studiul ACTT-1 dublu-orb, controlat cu placebo, efectuat pe mai mult de 1.000 de pacien\u021bi cu COVID-19, Veklury a \u00eembun\u0103t\u0103\u021bit rezultatele clinice pe o gam\u0103 larg\u0103 de evalu\u0103ri, incluz\u00e2nd \u00eembun\u0103t\u0103\u021birea semnificativ\u0103 a perioadei de recuperare \u0219i, de asemenea, reducerea probabilit\u0103\u021bii de progresie a bolii \u00een compara\u021bie cu placebo. Alte studii clinice interna\u021bionale de Faz\u0103 3, \u00een curs de desf\u0103\u0219urare, continu\u0103 s\u0103 evalueze eficacitatea \u0219i siguran\u021ba Veklury pentru tratamentul COVID-19, pe diferite popula\u021bii \u0219i categorii de pacien\u021bi \u0219i \u00een combina\u021bie cu alte terapii.<\/p>\n
Ca reac\u021bie la criza de s\u0103n\u0103tate actual\u0103 \u0219i pe baza datelor clinice disponibile, statutul de aprobare al Veklury variaz\u0103 \u00een func\u021bie de \u021bar\u0103. P\u00e2n\u0103 \u00een prezent, Veklury a fost aprobat sau autorizat pentru utilizare temporar\u0103 ca tratament COVID-19 \u00een aproximativ 50 de \u021b\u0103ri din \u00eentreaga lume.<\/p>\n
\u00cen Statele Unite, Agen\u021bia American\u0103 a Medicamentelor \u0219i Alimentelor (FDA) a acordat tratamentului Veklury o autoriza\u021bie de utilizare de urgen\u021b\u0103 (EUA) pentru tratarea pacien\u021bilor spitaliza\u021bi cu COVID-19. Aceast\u0103 autoriza\u021bie este temporar\u0103, poate fi revocat\u0103 \u0219i nu \u00eenlocuie\u0219te procesul formal de depunere, revizuire \u0219i aprobare a cererii de medicamente noi. Veklury nu a fost aprobat de FDA din SUA pentru nicio utilizare. Pentru informa\u021bii despre utilizarea autorizat\u0103 a Veklury \u0219i cerin\u021bele obligatorii ale EUA \u00een SUA, v\u0103 rug\u0103m s\u0103 consulta\u021bi Fi\u0219ele tehnice \u0219i Scrisoarea de autorizare FDA disponibile la www.gilead.com\/remdesivir.<\/p>\n
Despre Gilead Sciences<\/h6>\nGilead Sciences, Inc. este o companie biofarmaceutic\u0103 a c\u0103rei activitate se bazeaz\u0103 pe cercetare, care produce \u0219i comercializeaz\u0103 medicamente \u00een zone cu nevoi medicale nesatisf\u0103cute. Compania se str\u0103duie\u0219te s\u0103 transforme \u0219i s\u0103 simplifice \u00eengrijirea persoanelor cu boli care pun via\u021ba \u00een pericol, \u00een \u00eentreaga lume. Gilead activeaz\u0103 \u00een peste 35 de \u021b\u0103ri din \u00eentreaga lume, av\u00e2nd sediul central \u00een Foster City, California. Mai multe informa\u021bii privind r\u0103spunsul Giled \u00een ceea ce prive\u0219te pandemia de coronavirus sunt disponibile pe site-ul companiei, pe pagina dedicat\u0103: https:\/\/www.gilead.com\/purpose\/advancing-global-health\/covid-19.<\/h6>\nDeclara\u021bie anticipativ\u0103<\/h6>\nAcest comunicat de pres\u0103 cuprinde declara\u021bii anticipative \u00een sensul Legii privind reforma litigiilor \u00een materie de valori private din 1995, care sunt supuse riscurilor, incertitudinilor \u0219i altor factori, inclusiv riscul Comisiei Europeane de a nu extinde sau de a transforma autoriza\u021bia de comercializare condi\u021bionat\u0103 \u00eentr-o autoriza\u021bie de introducere pe pia\u021b\u0103 necondi\u021bionat\u0103 pentru Veklury ca tratament pentru COVID-19. Veklury este un medicament de investiga\u021bie care nu a fost aprobat de c\u0103tre US Food and Drug Administration (FDA) pentru nici o utilizare \u0219i nu se \u0219tie \u00eenc\u0103 dac\u0103 acesta este sigur sau eficient pentru tratarea COVID-19. Exist\u0103 posibilitatea rezultatelor nefavorabile din studiile clinice \u00een curs \u0219i suplimentare, care implic\u0103 Veklury, \u0219i posibilitatea ca Gilead sau alte p\u0103r\u021bi s\u0103 nu fie capabile s\u0103 finalizeze una sau mai multe dintre aceste studii \u00een termenele anticipate, \u00een prezent, sau deloc. Mai mult, exist\u0103 posibilitatea ca Gilead s\u0103 ia decizia strategic\u0103 de a opri produc\u021bia de Veklury, sau ca FDA sau alt\u0103 autoritate de reglementare s\u0103 nu aprobe Veklury, ori ca orice aprob\u0103ri de introducere pe pia\u021b\u0103, dac\u0103 sunt acordate, s\u0103 de\u021bin\u0103 limit\u0103ri semnificative \u00een ceea ce prive\u0219te utilizarea acestuia. Drept urmare, se poate ajunge \u00een situa\u021bia ca Veklury s\u0103 nu poat\u0103 fi comercializat cu succes. \u00cen completarea celor de mai sus, exist\u0103 riscul ca Gilead s\u0103 nu fie capabil\u0103 s\u0103 gestioneze eficient aprovizionarea \u0219i distribu\u021bia global\u0103 a Veklury. Aceste riscuri, incertitudini \u0219i al\u021bi factori ar putea face ca rezultatele reale s\u0103 fie diferite semnificativ de cele men\u021bionate \u00een declara\u021biile anticipative, astfel c\u0103 cititorii sunt sf\u0103tui\u021bi s\u0103 nu se bazeze pe aceste declara\u021bii anticipative. Aceste riscuri sunt detaliate \u00een Raportul Trimestrial privind formularul 10-Q pentru trimestrul \u00eencheiat la 30 iunie 2020, dup\u0103 cum a fost depus la Securities and Exchange Commission din SUA. Toate declara\u021biile anticipative se bazeaz\u0103 pe informa\u021biile disponibile \u00een prezent pentru Gilead, iar Gilead nu \u00ee\u0219i asum\u0103 nicio obliga\u021bie de a actualiza astfel de declara\u021bii anticipative.<\/h6>\n
<\/p>\n
<\/p>\n","protected":false},"excerpt":{"rendered":"
Acordul permite accesul rapid \u0219i echitabil la beneficiile clinice ale Veklury pentru pacien\u021bii COVID-19 eligibili, \u00een majoritatea \u021b\u0103rilor din UE \u0219i SEE Se estimeaz\u0103 c\u0103 prin extinderea accesului la […]<\/p>\n","protected":false},"author":4,"featured_media":6758,"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":[],"class_list":["post-6757","post","type-post","status-publish","format-standard","has-post-thumbnail","category-stiri-noutati"],"yoast_head":"\n
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