14-05-2015 00:14 | de | 12 afisari
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Toujeo®obţine aprobarea în Uniunea Europeană pentru tratamentul diabetului zaharat la adulți





- O insulină bazală de generație nouă,eficace în controlul glicemiei cu reducerea episoadelor confirmate de hipoglicemie -

 Sanofia anunța trecent că autorizația de punere pe piață în Europa pentru medicamentulToujeo® (insulină glargin [de origine ADNr] injectabilă, 300 U/ml)a fostemisă. Toujeo este o insulină bazală de nouă generațieindicată pentru tratamentul adulților cu diabet zaharat de tip 1 și 2.



"Obținereaautorizației de punere pe piață pentru Toujeo în Uniunea Europeană reprezintă un succes major pentru Sanofi, contribuind la extinderea portofoliului nostru integrat de soluții pentru persoanelecu diabet din Europa”, a declarat Pierre Chancel, Senior Vice-Preşedinte al Diviziei Globale Diabet a Sanofi. „Toujeo le oferă persoanelor cu diabet, precum şi medicilor, o nouă opțiunepentru gestionarea acestei boli şi reconfirmă angajamentul nostru de a oferi soluții de calitate pentru tratamentuldiabetului”.



Decizia Comisiei Europene de a aproba punerea pe piațăa medicamentului Toujeo se bazează pe rezultatele programului de studii clinice EDITION, care includemai multe studii internaționale de fază III, care au evaluat eficacitatea şi siguranța Toujeo,comparativ cu Lantus®(insulină glargin [de origine ADNr] injectabilă, 100 U/ml), la peste 3.500 de adulți cu diabet zaharat de tip1 sau 2,necontrolați cutratamentulactual1-6.



Studiile au demonstrat că Toujeoeste comparabil cu Lantus în ceea ce privește controlul glicemiei, având un profil de siguranță favorabil. Incidența evenimentelor confirmate de hipoglicemie a fost mai scăzută în cazul administrării Toujeo, comparativ cu Lantus, în orice moment din zi şi în timpul nopții, la adulții cu diabet zahat de tip 27. De asemenea, Toujeo a demonstrat, comparativ cu Lantus, un control al glicemiei mai stabil şi mai previzibil, precum şi o variabilitate scăzută a glicemiei, efect care durează peste 24 de ore la adulții cu diabet zaharat de tip 18-10.



"Majoritatea persoanelor care au diabet şi necesită insulinăîncă nu reușesc să atingă un nivel de control adecvat al glicemiei!”,a declarat Profesorul Robert Ritzel, Head of the Clinic of Endocrinology, Diabetology and Addiction Medicine, Klinikum Schwabing, Städtisches Klinikum München GmbH, Munich, Germania. „Oferind un control stabil al glicemiei şi o variabilitate redusă, precum şi reducerea evenimentelor de hipoglicemie la persoanele cu diabet zaharat de tip 2, Toujeo reprezintă o nouă soluţie pentru a răspunde acestor nevoi nerezolvate.”

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