{"id":4275,"date":"2015-05-11T11:26:32","date_gmt":"2015-05-11T11:26:32","guid":{"rendered":"https:\/\/jurmed.ro\/medici\/?p=4275"},"modified":"2015-05-11T11:26:32","modified_gmt":"2015-05-11T11:26:32","slug":"toujeoobtine-aprobarea-in-uniunea-europeana-pentru-tratamentul-diabetului-zaharat-la-adulti","status":"publish","type":"post","link":"https:\/\/jurmed.ro\/medici\/toujeoobtine-aprobarea-in-uniunea-europeana-pentru-tratamentul-diabetului-zaharat-la-adulti\/","title":{"rendered":"\u00a0Toujeo\u00aeob\u0163ine aprobarea \u00een Uniunea European\u0103 pentru tratamentul diabetului zaharat la adul\u021bi"},"content":{"rendered":"

\"sanofi\"<\/a>– O insulin\u0103 bazal\u0103 de genera<\/em><\/strong>\u021b<\/em><\/strong>ie nou\u0103,eficace \u00een controlul glicemiei\u00a0cu reducerea episoadelor confirmate de \u00a0–<\/em><\/strong><\/p>\n

\u00a0<\/strong>Sanofi<\/a>a anun\u021ba recent c\u0103 autoriza<\/strong>\u021b<\/strong>ia de punere pe pia<\/strong>\u021b<\/strong>\u0103 \u00een Europa pentru medicamentulToujeo<\/strong>\u00ae<\/sup><\/strong> (insulin\u0103 glargin [de origine ADNr] injectabil\u0103, 300 U\/ml)a fostemis\u0103. Toujeo este o insulin\u0103 bazal\u0103 de nou\u0103 genera\u021bieindicat\u0103 pentru tratamentul adul\u021bilor cu diabet zaharat de tip 1 \u0219i 2.<\/p>\n

„Ob<\/em>\u021b<\/em>inereaautoriza<\/em>\u021b<\/em>iei de punere pe pia<\/em>\u021b<\/em>\u0103 pentru Toujeo \u00een Uniunea European\u0103 reprezint\u0103 un succes major pentru Sanofi, contribuind la extinderea portofoliului nostru integrat de solu<\/em>\u021b<\/em>ii pentru persoanele cu diabet din Europa<\/em>\u201d, a declarat Pierre Chancel, Senior Vice-Pre\u015fedinte al Diviziei Globale Diabet a Sanofi. \u201eToujeo le ofer\u0103 persoanelor cu diabet, precum \u015fi medicilor, o nou\u0103 op<\/em>\u021b<\/em>iunepentru gestionarea acestei boli \u015fi reconfirm\u0103 angajamentul nostru de a oferi solu<\/em>\u021b<\/em>ii de calitate pentru tratamentuldiabetului\u201d.<\/em><\/p>\n

Decizia Comisiei Europene de a aproba punerea pe pia\u021b\u0103a medicamentului Toujeo se bazeaz\u0103 pe rezultatele programului de studii clinice EDITION, care includemai multe studii interna\u021bionale de faz\u0103 III, care au evaluat eficacitatea \u015fi siguran\u021ba Toujeo, comparativ cu Lantus\u00ae<\/sup>(insulin\u0103 glargin [de origine ADNr] injectabil\u0103, 100 U\/ml), la peste 3.500 de adul\u021bi cu diabet zaharat de tip1 sau 2,necontrola\u021bi cutratamentulactual1-6<\/sup>.<\/p>\n

Studiile au demonstrat c\u0103 Toujeoeste comparabil cu Lantus \u00een ceea ce prive\u0219te controlul glicemiei, av\u00e2nd un profil de siguran\u021b\u0103 favorabil. Inciden\u021ba evenimentelor confirmate de hipoglicemie a fost mai sc\u0103zut\u0103 \u00een cazul administr\u0103rii Toujeo, comparativ cu Lantus, \u00een orice moment din zi \u015fi \u00een timpul nop\u021bii, la adul\u021bii cu diabet zahat de tip 27<\/sup>. De asemenea, Toujeo a demonstrat, comparativ cu Lantus, un control al glicemiei mai stabil \u015fi mai previzibil, precum \u015fi o variabilitate sc\u0103zut\u0103 a glicemiei, efect care dureaz\u0103 peste 24 de ore la adul\u021bii cu diabet zaharat de tip 18-10<\/sup>.<\/p>\n

„<\/em>Majoritatea persoanelor care au diabet \u015fi necesit\u0103 insulin\u0103 \u00eenc\u0103 nu reu<\/em>\u0219<\/em>esc s\u0103 ating\u0103 un nivel de control adecvat al glicemiei!\u201d,\u00a0<\/em>a declarat Profesorul Robert Ritzel, Head of the Clinic of Endocrinology, Diabetology and Addiction Medicine, Klinikum Schwabing, St\u00e4dtisches Klinikum M\u00fcnchen GmbH, Munich, Germania. \u201eOferind un control stabil al glicemiei \u015fi o variabilitate redus\u0103, precum \u015fi reducerea evenimentelor de hipoglicemie la persoanele cu diabet zaharat de tip 2, Toujeo reprezint\u0103 o nou\u0103 solu\u0163ie pentru a r\u0103spunde acestor nevoi nerezolvate.\u201d <\/em><\/p>\n

Autoriza\u021bia de punere pe pia\u021b\u0103 acordat\u0103 pentru Toujeode Comisia European\u0103 este aplicabil\u0103 \u00een cele 28 de state membre ale Uniunii Europene, precum \u015fi \u00een Islanda, Liechtenstein \u015fi Norvegia, fiind precedat\u0103 de avizul favorabil acordat de Comitetul pentru Medicamente de Uz Uman (CHMP) al Agen\u021biei Europene a Medicamentului (EMA),din 26 februarie. Toujeo a fost aprobat de Administra\u021biaAmerican\u0103 pentru Alimente \u015fi Medicamente (FDA) \u015fi este evaluat, \u00een acest moment, \u015fi de alte autorit\u0103\u021bi de reglementare din lume.<\/p>\n

Despre Toujeo<\/strong><\/p>\n

Cu toate c\u0103 insulina bazal\u0103 este un standard \u00een tratamentul pentru diabet zaharat de mai multe decenii, exist\u0103, \u00een continuare,nevoi medicale semnificative neacoperite, aproape jum\u0103tate dintre persoanele cu diabettratateneajung\u00e2nd s\u0103-\u015fi ating\u0103 valorile \u0163int\u0103 ale glicemiei11<\/sup>-16<\/sup>. \u00cen plus, este, adesea, dificil s\u0103 se ajung\u0103 la doza optim\u0103 de insulin\u0103, \u00een faza de ini\u0163iere sau \u00eentre\u0163inere. Toujeo\u00ae<\/sup> este o insulin\u0103 bazal\u0103 analog de nou\u0103 genera\u0163ie, care se administreaz\u0103 o singur\u0103 dat\u0103 pe zi \u015fi con\u0163ine o substan\u021b\u0103 activ\u0103(insulina glargin), care are un raport risc\/beneficiu bine stabilit17<\/sup>. Depozitul compact pe care \u00eel formeaz\u0103 la nivel subcutanat determin\u0103 un profil farmacocinetic\/farmacodinamic mai stabil \u015fi mai prelungit8-10<\/sup>.<\/p>\n

Rezultatele ob\u021binute\u00eenprogramul de studii clinice EDITION au demonstrat c\u0103,din punct de vedere al eficacit\u0103\u021bii, controlul glicemiei dup\u0103 administrarea Toujeo este comparabil cu cel ob\u021binut cu ajutorul Lantus. La pacien\u021bii cu diabet zaharat de tip 2 care au primit asociat,fie medica\u021bie anti-hiperglicemic non-insulinic, fie insulin\u0103 prandial\u0103,inciden\u021ba evenimentelor de hipoglicemie confirmate (\u00een orice moment din zi \u015fi noapte) a fost mai sc\u0103zut\u0103 la pacien\u021biitrata\u021bi cu Toujeo, comparativ cu cei trata\u021bi cu Lantus.Acest fapta fost eviden\u021biat printr-o reducere cu 18% a riscului la pacien\u021bii cu diabet zaharat de tip 2 trata\u021bi cu insulin\u0103 bazal\u0103 \u00een asociere, fie cu un medicament anti-hiperglicemic non-insulinic,\u0219i o reducere cu 21%, la cei care asociauinsulina prandial\u0103, \u00eencep\u00e2nd cu s\u0103pt\u0103m\u00e2na a noua \u015fi p\u00e2n\u0103 la finalul perioadei de studiu. \u00cen general, aceste efecte asupra riscului de hipoglicemie au fost constante,indiferent de v\u00e2rst\u0103, gen, IMC \u015fi durata diabetului (sub 10 ani \u015fi egal\u0103 sau mai mare de 10 ani), la pacien\u021biitrata\u021bi cu Toujeo comparativ cu cei trata\u021bi cu Lantus. La pacien\u021bii cu diabet zaharat de tip 1 la care s-a administrat Toujeo, inciden\u021ba episoadelor de hipoglicemie a fost similar\u0103 comparativ cu cei trata\u021bi cu Lantus.18<\/sup><\/p>\n

Despre<\/strong>Divizia de Diabet a Sanofi <\/strong><\/p>\n

Sanofi \u015fi-a asumat angajamentul de a-i ajuta pe pacien\u021bi s\u0103 gestioneze provoc\u0103rile complexe pe care le presupune diabetul, prin solu\u021bii inovatoare, integrate \u015fi personalizate. Pornind de la contribu\u021biile valoroase ale persoanelor care tr\u0103iesc cu aceast\u0103 boal\u0103, compania \u00eencheie parteneriate pentru a oferi solu\u021bii de diagnosticare, terapii, servicii \u015fi dispozitive, inclusiv sisteme inovatoare de monitorizare a glicemiei. Sanofi comercializeaz\u0103 medicamente injectabile, inhalabile \u015fi orale pentru persoanele cu diabet zaharat de tip 1 sau 2.<\/p>\n

Despre Sanofi<\/strong><\/p>\n

Sanofi, lider mondial \u00een produc\u021bia de medicamente, descoper\u0103, dezvolt\u0103 \u0219i distribuie solu\u021bii terapeutice pentru a \u00eembun\u0103t\u0103\u021bi via\u021ba tuturor oamenilor. Sanofi de\u0163ine atuuri importante \u00een domeniul s\u0103n\u0103t\u0103\u0163ii \u015fi se bazeaz\u0103 pe 7 platforme de cre\u015ftere: solu\u0163ii pentru diabet, vaccinuri de uz uman, produse inovatoare, boli rare, produse f\u0103r\u0103 prescrip\u0163ie medical\u0103, pie\u0163e emergente \u015fi s\u0103n\u0103tatea animalelor. Sanofi este cotat\u0103 la bursele de valori din Paris (EURONEXT: SAN) \u015fi New York (NYSE: SNY)<\/p>\n

Referin\u0163e<\/strong><\/p>\n

    \n
  1. Riddle MC, et al. Diabetes Care. 2014;37(10):2755-62. DOI: 10.2337\/dc14-0991.<\/li>\n
  2. Yki-J\u00e4rvinen H, et al. Diabetes Care. 2014;37(12):3235-43. DOI: 10.2337\/dc14-0990.<\/li>\n
  3. Bolli GB, et al. Diabetes Obes Metab. 2015:epub ahead of print. DOI: 10.1111\/dom.12438.<\/li>\n
  4. Home P, et al. Oral presentation abstract #148 presented at EASD, Vienna, September 15-19, 2014. Available from http:\/\/www.easdvirtualmeeting.org\/resources\/16864<\/a>. Date accessed: April 2015.<\/li>\n
  5. Matsuhisa M, et al. ePoster abstract #975 presented at EASD, Vienna, September 15-19, 2014. Available from http:\/\/www.easdvirtualmeeting.org\/resources\/17806<\/a>. Date accessed: April 2015.<\/li>\n
  6. Terauchi Y, et al. ePoster abstract #976 presented at EASD, Vienna, September 15-19, 2014. Available from http:\/\/www.easdvirtualmeeting.org\/resources\/17807<\/a>. Date accessed: April 2015.<\/li>\n
  7. Ritzel R, et al. ePoster abstract #963 presented at EASD, Vienna, September 15-19, 2014. Available from http:\/\/www.easdvirtualmeeting.org\/resources\/18908<\/a>. Date accessed: April 2015.<\/li>\n
  8. Steinstraesser A, et al. Diabetes Obes Metab. 2014;16(9):873-6. DOI: 10.1111\/dom.12283.<\/li>\n
  9. Becker RHA, et al. Diabetes Care. 2015;38(4):637-43. DOI: 10.2337\/dc14-0006.<\/li>\n
  10. Shiramoto M, et al. Diabetes Obes Metab. 2015;17(3):254-60. DOI: 10.1111\/dom.12415.<\/li>\n
  11. Banegas JR, et al. Eur Heart J. 2011;32(17):2143-52. DOI: 10.1093\/eurheartj\/ehr080.<\/li>\n
  12. Stark Casagrande S, et al. Diabetes Care. 2013;36(8):2271-9. DOI: 10.2337\/dc12-2258.<\/li>\n
  13. Chan JCN, et al. Diabetes Care. 2009;32(2):227-33. DOI: 10.2337\/dc08-0435.<\/li>\n
  14. Choi YJ, et al. Diabetes Care. 2009;32(11):2016-20. DOI: 10.2337\/dc08-2228.<\/li>\n
  15. Steinberg BA, et al. American Heart Journal. 2008;156(4):719-27. DOI: 10.1016\/j.ahj.2008.05.020.<\/li>\n
  16. Vouri SM, et al. Journal of managed care pharmacy : JMCP. 2011;17(4):304-12.<\/li>\n
  17. Gerstein HC, et al. N Engl J Med. 2012;367(4):319-28. DOI: 10.1056\/NEJMoa1203858.<\/li>\n
  18. Toujeo\u00ae<\/sup> EU Summary of Product Characteristics, 2015.<\/li>\n<\/ol>\n

    Declara<\/em><\/strong>\u021b<\/em><\/strong>ii cu caracter previzional Sanofi<\/em><\/strong><\/p>\n

    Prezentul comunicat de pres\u0103 con<\/em>\u021b<\/em>ine declara<\/em>\u021b<\/em>ii cu caracter previzional (forward-looking statements) \u00een sensul Private Securities Litigation Reform Act din 1995, cu modific\u0103rile ulterioare. Declara<\/em>\u021b<\/em>iile cu caracter previzional sunt acele declara<\/em>\u021b<\/em>ii care nu au un caracter istoric. Aceste declara<\/em>\u021b<\/em>ii includ proiec<\/em>\u021b<\/em>ii \u015fi estim\u0103ri, precum \u015fi supozi<\/em>\u021b<\/em>iile \u015fi declara<\/em>\u021b<\/em>iile care stau la baza acestora \u015fi care se refer\u0103 la planurile, obiectivele, inten<\/em>\u021b<\/em>iile \u015fi a<\/em>\u0219<\/em>tept\u0103rile legate de rezultatele financiare, evenimentele, opera<\/em>\u021b<\/em>iunile, serviciile, dezvolt\u0103rile de produse \u015fi poten<\/em>\u021b<\/em>ialul produselor \u00een viitor, precum \u015fi declara<\/em>\u021b<\/em>iile privind performan<\/em>\u021b<\/em>a viitoare. Declara<\/em>\u021b<\/em>iile cu caracter previzional sunt \u00een general identificate prin cuvintele \u201ea<\/em>\u0219<\/em>teapt\u0103\u201d, \u201eanticipeaz\u0103\u201d, \u201econsider\u0103\u201d, \u201einten<\/em>\u021b<\/em>ioneaz\u0103\u201d, \u201eestimeaz\u0103\u201d, \u201eplanific\u0103\u201d \u015fi alte expresii similare. De<\/em>\u0219<\/em>i managementul Sanofi consider\u0103 c\u0103 a<\/em>\u0219<\/em>tept\u0103rile reflectate de declara<\/em>\u021b<\/em>iile cu caracter previzional sunt rezonabile, investitorii sunt avertiza<\/em>\u021b<\/em>i c\u0103 informa<\/em>\u021b<\/em>iile \u015fi declara<\/em>\u021b<\/em>iile cu caracter previzional se supun diferitelor riscuri \u015fi incertitudini, multe din acestea fiind dificil de previzionat \u015fi fiind \u00een general \u00een afara controlului Sanofi, ceea ce poate conduce la diferen<\/em>\u021b<\/em>e semnificative \u00eentre rezultatele \u015fi evolu<\/em>\u021b<\/em>iile reale \u015fi cele care sunt exprimate, implicate sau proiectate prin declara<\/em>\u021b<\/em>iile \u015fi informa<\/em>\u021b<\/em>iile cu caracter previzional. Aceste riscuri \u015fi incertitudini includ, printre altele, incertitudinile inerente activit\u0103<\/em>\u021b<\/em>ilor de cercetare \u015fi dezvoltare, datele \u015fi analizele clinice viitoare, inclusiv post marketing, deciziile autorit\u0103<\/em>\u021b<\/em>ilor de reglementare, cum ar fi FDA sau EMA, cum ar fi cele referitoare la dac\u0103 \u015fi c\u00e2nd s\u0103 aprobe o cerere pentru un medicament, dispozitiv sau produs biologic, ce poate fi depus\u0103 pentru orice astfel de produse candidate, precum \u015fi deciziile acestora referitoare la etichetare \u015fi alte chestiuni care ar putea afecta disponibilitatea sau poten<\/em>\u021b<\/em>ialul comercial al acestor produse candidate, absen<\/em>\u021b<\/em>agaran<\/em>\u021b<\/em>iei c\u0103 produsele candidate vor avea succes comercial, aprobarea viitoare \u015fi succesul comercial viitor al alternativelor terapeutice, precum \u015fi cele discutate sau identificate \u00een documentele publice depuse la SEC \u015fi AMF de Sanofi, inclusiv cele men<\/em>\u021b<\/em>ionate la rubrica \u201efactori de risc\u201d \u015fi \u201edeclara<\/em>\u021b<\/em>ii prudente privind declara<\/em>\u021b<\/em>iile cu caracter previzional\u201d din raportul anual al Sanofi din Formularul 20-F pentru anul \u00eencheiat la 31 decembrie 2014. Sanofi nu \u00ee<\/em>\u0219<\/em>i asum\u0103 angajamentul de a actualiza sau revizui informa<\/em>\u021b<\/em>iile \u015fi declara<\/em>\u021b<\/em>iile cu caracter previzional, sub rezerva reglement\u0103rilor aplicabile<\/em>.<\/em><\/p>\n

    \n

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