B - Tripla

Richiesta approvazione in america all'FDA, per B-Tripla (Atripla senza efavirenz (sustiva)).
Al posto del Sustiva c'e' la rilpivirine.
Sempre 1 al giorno.

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November 24, 2010

Gilead Submits Application for FDA Approval for a New Single-Pill HIV Regimen


Gilead announced November 23 that is has submitted a new drug application (NDA) to the U.S. Food and Drug Administration for a single-pill once-daily tablet that combines Tibotec’s experimental drug rilpivirine (TMC278) with Gilead’s Truvada (tenofovir and emtricitabine). If approved, it would become the second all-in-one, single-pill HIV regimen available in the United States.

During the past decade, the number of antiretroviral pills that a person must take has grown smaller and smaller. This trend culminated in 2006 with the release of Atripla, which contains the non-nucleoside reverse transcriptase inhibitor (NNRTI) Sustiva (efavirenz), with two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir and emtricitabine. The manufacture and marketing of the drug represented another first in the history of HIV drug development, which was the partnership of two independent drug companies, Bristol-Myers Squibb—the maker of Sustiva—and Gilead.

Now, a new second-generation NNRTI, rilpivirine, is in the last stages of development. In clinical trials reported so far, it has shown similar potency to Sustiva, but with fewer side effects. Once again, Gilead will be partnering with another company, in this case Tibotec (a subsidiary of Johnson & Johnson), which is developing rilpivirine as a stand-alone drug as well.

The submission of an NDA is the start of the final process for FDA approval. Historically, most AIDS drugs have been approved within a year of NDA submission. Gilead and Tibotec filed paperwork for European approval of the drug on September 3.


Search: Gilead, Tibotec, Johnson & Johnson, emtricitabine, tenofovir, Truvada, Sustiva, efavirenz, TMC278, rilpivirine, FDA

Ciao Gex, questa sarebbe un'ottima cosa davvero.
Molti sono risultati intolleranti all'Efavirenz, anche con gravi eruzioni cutanee, tali da dover sospendere il trattamento. E sarebbe un traguardo importante avere un'alternativa "all'unica somministrazione" giornaliera, proprio per queste persone intolleranti.
Grazie dell'aggiornamento.
Miki

beccato in pieno ...io ho avuto un rush cutaneo, solo che l'infettivologo mi disse che solo uno su mille ha questa allergia...poi ho visto sui forum un bel numero di persone con lo stesso problema. speriamo che presto arrivi in Italia.

pure io faccio parte del numero, ho dovuto sospendere sustiva dopo pochi mesi per un'eruzione cutanea fortissima, anzi ho dovuto sospendere ogni terapia ed assumere un paio di mesi di cortisone perchè rientrasse tutto!
A parte che sustiva non lo tolleravo proprio per tutta una serie di altri disturbi, l'insonnia (per me che già fatico a dormire), le vertigini, acufeni terribili...
aspettiamo la b.tripla allora!!

Idem dalla mia mezza mela (la parte buona intendo, non io!!! eheheh) che ha avuto una forte reazione, tanto da costringere a sospendere e come Glorietta, prendere cortisone per rientrare nella norma (pero' non per mesi, ma solo settimane, fortunatamente!!)

La Gilead ha risposto alla richiesta di chiarimenti della Fda che non aveva approvato l'immissione in commercio del farmaco, rinviando il dossier.
La Fda aveva contestato tracce di impurita nella nuova pillola in quantita non accettabili.
Adesso la Fda ha 2 mesi di tempo per decidere se approvare il farmaco o rigettare indietro il dossier.


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February 11, 2011

Gilead and Tibotec’s Combo HIV Drug Is Back on Track


Gilead announced that it is back on track with the approval process for the combination antiretroviral (ARV) pill it is developing in partnership with Tibotec, having refiled its New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). The FDA rejected the original NDA in a letter dated January 25 over concerns about impurities found during test-batches of the new pill.

Gilead initially filed for approval of the fixed-dose combination tablet—which combines Tibotec’s rilpivirine (TMC278) with Gilead’s Truvada (tenofovir plus emtricitabine)—in November 2010. However, the FDA sent Gilead a “refuse to file” notification in late January, asking the company to provide further information about how the company came to determine what constitutes acceptable levels of “degradents” of emtricitabine that occurred while manufacturing the new combo pill. Drugs sometimes contain trace impurities, and it is the manufacturer’s responsibility to prove to the FDA the maximum levels of the impurity that the drug can contain and still remain safe and effective for people who take it. These data were included in the new filing Gilead just sent to the FDA.

Gilead reported in January that the refusal to file meant that when it resubmitted the application the drug could still receive priority review, which can shave months off the approval process. The FDA now has two months to decide whether the application is sufficient to proceed with the approval process—and to set a target date for approval.


Search: Gilead, Tibotec, combo pill, fixed-dose combination, rilpivirine, TMC278, new drug application, FDA, Truvada, tenofovir, emtricitabine


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Grazie per gli aggiornamenti prezioso Gex!!