 |
HCVJEVCI
HEPATITIS C - UNIČIMO GA !
|
| Poglej prejšnjo temo :: Poglej naslednjo temo |
| Avtor |
Sporočilo |
ELI
Administrator foruma
Pridružen/-a: 31.05. 2006, 18:14
Prispevkov: 824
Kraj: Ljubljana
|
 Objavljeno: 12 Feb 2011 23:22 Naslov sporočila: TELAPREVIR-NOVO DODATNO ZDRAVILO ZA ZDRAVLJENJE HCV |
 |
|
TUKAJ JE SKOPIRAN ČLANEK O TELAPREVIRJU IN SLABŠI PREVOD SPODAJ POD NJIM:
FDA accepts Vertex's telaprevir NDA for six-month Priority Review
20. January 2011 08:39
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) announced today that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for telaprevir and granted the company's request for six-month Priority Review. Telaprevir is Vertex's lead medicine in development for people with genotype 1 chronic hepatitis C. The FDA grants Priority Review to medicines that offer major advances in treatment or provide a treatment where no adequate therapy exists. A target review date of May 23, 2011 is set under the Prescription Drug User Fee Act (PDUFA) for the FDA's approval decision, which is four months earlier than the standard review time of 10 months.
“Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment”
Additionally, Vertex today announced the completion of a New Drug Submission (NDS) to the Therapeutic Product Directorate (TPD) of Health Canada seeking approval for telaprevir in Canada. Telaprevir was also granted Priority Review in Canada, which allows for faster review for promising medicines that address life-threatening or severely debilitating conditions and for which there are few effective therapies already available. Standard review in Canada takes 18 months or more and Priority Review typically shortens the review time to approximately six to nine months.
In December 2010, Janssen-Cilag International NV announced that the European Medicines Agency (EMA) accepted telaprevir for accelerated assessment in Europe, which is granted to new medicines of major public health interest.
"Data from Phase 3 studies showed that when compared to currently available medicines, telaprevir-based combination therapy nearly doubled viral cure rates and cut treatment time in half for the majority of patients new to treatment," said Peter Mueller, Ph.D., Chief Scientific Officer and Executive Vice President of Global Research and Development at Vertex. "We look forward to working with the FDA and Health Canada to make telaprevir available as quickly as possible for people with hepatitis C."
SOURCE Vertex
PREVOD IZ GOOGLA:
FDA sprejema telaprevir NDA Vertexovo za šestmesečno Prednost Pregled
20. Januar 2011 08:39
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) je danes objavil, da je US Food and Drug Administration (FDA) je sprejela New Drug Application (NDA) za telaprevir in odobri zahtevek družbe za šestmesečno Prednost Review. Telaprevir je povzročilo zdravilo Vertexovo v razvoju za ljudi z genotipom 1 kroničnim hepatitisom C. FDA donacij Prednost Review do zdravil, ki ponuja velik napredek v zdravljenju ali zagotoviti obdelavo, kjer ni ustrezne terapije obstaja. Ciljni Pregled datum 23. maj 2011 je določen na podlagi zdravil na recept za uporabo Fee Act (PDUFA) za sklep o odobritvi FDA, ki je štiri mesece prej, kot je standard času pregleda 10 mesecev.
"Podatki iz faze 3 študije so pokazale, da v primerjavi s trenutno na voljo zdravila, telaprevir temelji na kombinirano zdravljenje skoraj podvojile virusne stopnje ozdravitve in zmanjšanje časa zdravljenja v polletju za večino bolnikov novega na zdravljenje"
Poleg tega, Vertex je danes napovedal zaključek New Drug Oddaja (NDS) za terapevtske Product direktorata (TPD) za zdravje Canada ki želijo pridobiti odobritev za telaprevir v Kanadi. Telaprevir je bila dodeljena tudi Prednost Review v Kanadi, ki omogoča hitrejšo oceno za obetavno zdravila, ki-naslov smrtno nevarne oziroma resno izčrpavajoče pogoje in za katere obstaja nekaj učinkovitih zdravljenj že na voljo. Standard pregled v Kanadi traja 18 mesecev ali več, in prednostno nalogo pregled običajno skrajšuje čas za nadzor približno šest do devet mesecev.
V decembru 2010, Janssen-Cilag International NV je sporočil, da je sprejela Evropska agencija za zdravila (EMA) telaprevir za pospešeno oceno v Evropi, ki je bila izdana za nove zdravila večjih interesu javnega zdravja.
"Podatki iz faze 3 študije so pokazale, da v primerjavi s trenutno na voljo zdravila, telaprevir temelji na kombinirano zdravljenje skoraj podvojile virusne stopnje ozdravitve in zmanjšanje časa zdravljenja v polletju za večino bolnikov novega na zdravljenje," je dejal Peter Mueller, Ph.D., vodja znanstvenega delavca in izvršni podpredsednik Global raziskave in razvoj na Vertex. "Veselimo se sodelovanja z FDA in Health Canada, da telaprevir dostopni kakor hitro je mogoče, da ljudje z virusom hepatitisa C."
VIR Vertex |
|
| Nazaj na vrh |
|
 |
|
|
Ne, ne moreš dodajati novih tem v tem forumu
Ne, ne moreš odgovarjati na teme v tem forumu
Ne, ne moreš urejati svojih prispevkov v tem forumu
Ne, ne moreš brisati svojih prispevkov v tem forumu
Ne ne moreš glasovati v anketi v tem forumu
|
|
Pogosta vprašanja
Išči
Seznam članov
Skupine uporabnikov
RSS Feed
Registriraj se
Tvoj profil
Zasebna sporočila
Prijava
