GSK2248761 (noto anche come IDX899

GSK2248761 (noto anche come IDX899) e' un nuovo non-nucleoside reverse transcriptase inhibitor in sperimentazione.
Il farmaco e' della Idenix Pharmaceuticals, Inc, azienda farmaceutica specializzata in farmaci biotecnologici.
L'azienda ha anche altre interessanti novita' per l'HCV.

[Devi essere iscritto e connesso per vedere questo link]

Idenix announces updates on HCV and HIV clinical development programs
10. February 2011 06:26



Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced updates to three clinical development programs.

IDX184, a liver-targeted HCV nucleotide prodrug

The U.S. Food and Drug Administration (FDA) has verbally informed Idenix that the full clinical hold for IDX184 has been removed. The program has been placed on partial clinical hold, and Idenix anticipates initiating a Phase IIb12-week trial of IDX184 in combination with pegylated interferon and ribavirin in the second half of 2011.

The clinical hold was issued in September 2010 as a result of three cases of elevated liver function tests observed during a drug-drug interaction study of the combination of IDX184 and IDX320, an HCV protease inhibitor, in healthy volunteers. Idenix reviewed available data and conducted additional preclinical studies. With the help of independent experts and an external safety committee, the company concluded that the observed toxicity was likely caused by IDX320. Idenix submitted a response to the clinical hold to the FDA in January 2011.

IDX320, an HCV protease inhibitor

Based on Idenix's conclusion that the observed toxicity in the drug-drug interaction study was likely caused by IDX320, the company has discontinued the development of IDX320. Next generation protease inhibitors that may potentially avoid the observed hepatotoxicity are in preclinical development at Idenix.

GSK2248761 ('761, formerly IDX899), an HIV non-nucleoside reverse transcriptase inhibitor

Idenix was informed by ViiV Healthcare Company (ViiV), an affiliate of GlaxoSmithKline (GSK), that '761, a non-nucleoside reverse transcriptase inhibitor drug candidate for the treatment of HIV/AIDS licensed by Idenix to GSK, was placed on clinical hold by the FDA. ViiV has full responsibility for the development of '761, including any regulatory interactions.

Under the collaboration arrangement between Idenix and GSK, Idenix has received $60.5 million in license fees, equity investment and milestone payments to date and is eligible to receive up to $390.0 million in additional milestone payments as well as double-digit tiered royalties on worldwide product sales.

SOURCE Idenix Pharmaceuticals, Inc.

Scusa Gex, ma è gia stato approvato per
essere commercializzato? Un bacione

Jago ha scritto:Scusa Gex, ma è gia stato approvato per
essere commercializzato? Un bacione

No purtroppo hanno presentato solo richiesta di autorizzazione all' FDA.
funziona cosi:
1 si scopre una molecola nuova (o vecchia)
2 si fanno studi fase 1 Dosaggio (dose finding) e sicurezza (che non ammazzano la gente)
3 se questi danno una prova di sicurezza si fanno studi di fase 2
3 se questi danno prove di efficacia si fanno studi di fase 3
4 si prepara il dossier da presentare all' FDA (ente sanitario americano)
5 Se lo ritiene l' FDA da autorizzazione al commercio
6 Si prepara dossier per EMEA (ente sanitario europeo)
7 Se lo ritiene l'EMEA da autorizzazione
8 Se l'Aifa (ente italiano) lo ritiene necessario da l'autorizzazione al commercio in Italia pubblicando il prezzo su gazzetta ufficiale.
9 Si deve inserire il nuovo farmaco nei prontuari regionali
10 viene inserito il nuovo farmaco nei prontuari ospedalieri dei singoli ospedali
11 finalmente il medico puo' prescriverlo.
come vedi e' un po' lunga la via...

Notizia fresca fresca
L'fda ha messo un freno a questo farmaco dicendo che gli studi di fase 1 e 2 sono un po miseri.. quindi forse vorranno nuovi studi..
Questo rallentera' un po' la messa in commercio...


[Devi essere iscritto e connesso per vedere questo link]

February 10, 2011

FDA Puts a Hold on Development of ViiV HIV Drug


ViiV Healthcare announced that the U.S. Food and Drug Administration (FDA) has placed a hold on the development of a non-nucleoside reverse transcriptase inhibitor (NNRTI) that it was studying, a drug it had licensed from Idenix Pharmaceuticals in 2009.

The reason for the FDA development hold on GSK-2248761 (GSK-761; formerly known as IDX899) involved four reports of seizures as part of a clinical trial involving treatment-experienced patients. “As a result,” the company told HIV treatment activists on February 11, “the responsible course of action is to put the [GSK-761] studies on hold while we gather more information. The clinical team is now in the process of gathering further information on the cases in order to provide further guidance on next steps with [the drug].”

GSK-761 has been previously studied in several small Phase I and Phase IIa trials, and it was currently in two Phase IIb studies, including the one in which the seizures were reported. In earlier trials, the drug had shown effectiveness at low once-daily doses, and it was active against strains of HIV that are resistant to other NNRTIs.

“Two letters have been sent to the study investigators informing them of the serious adverse events,” explained the company officials. “These letters provide a summary of the adverse events, and guidance that investigators are to contact their patients, inform them of the risk of seizures and bring them in as soon as possible to change their medication from [GSK-761] to a suitable alternative and arrange for follow up care.

“This does not mean that the overall development program of [GSK-761] has been halted,” the company added.


Search: ViiV Healthcare, Idenix, IDX899, GSK-2248761, GSK-761, FDA, hold, side effects, seizures, NNRTI, non-nucleoside reverse transcriptase inhibitor