tenofovir fda approval

I believe the results are from clinical trials of ETV submitted to FDA when seeking approval. A wide selection of patients was included in these trials, including patients with decompensated cirrhosis. So is this 6% HCC due to ETV or is it normal for this special population of HBV patients? I think there is an ongoing phase 4 studies of ETV to monitor any events related to HCC. So far, FDA has not issued any warning.

Arrowhead Research Corporation, a biopharmaceutical company specializing in creating targeted RNAi therapies, recently submitted an application to the U.S. Food and Drug Administration (FDA) for further testing of a new drug, called ARC-520, to treat chronic hepatitis B virus infection. Arrowhead is seeking authorization to begin Phase 2b randomized double-blind placebo-controlled multi-dose studies in multiple locations.

The medications currently approved by the US Food and Drug Administration (FDA) for the initial treatment of chronic hepatitis B include interferon alfa-2b, peginterferon alfa-2a, and the oral nucleoside/nucleotide analogs lamivudine, adefovir dipivoxil, entecavir, and telbivudine, with tenofovir under FDA review for likely approval in 2008. Each of these drugs has a number of advantages and disadvantages.

The FDA must approve or disapprove of telaprevir on or before May 23 of this year. How long it will take to get on the drug formularies is something we do not know yet.

The doc is viral hepatitis expert who was originally involved clinical trials for fibroscan FDA approval in the US. I have been informed that hbsag quant test is in review and may get approved in "near future". No specifics on time frame though.

As GS-7340 is more efficacious than tenofovir do you think that by its approval(hope soon as studies are underway in Hiv patients) will lead to the approval of this drug for Hepatitis B and are we expecting more hbv seroconversions(used in combo or mono)? Waiting for any answers.

I was offered to apply for the study, but I am going to wait for the approval from the FDA.

The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. Approval of a drug based on such endpoints is given on the condition that post marketing clinical trials verify the anticipated clinical benefit. The FDA bases its decision on whether to accept the proposed surrogate endpoint on the scientific support for thatendpoint.

You can thank our FDA for this delay. Here is an example of how their drug approval process kills thousands of people each year! http://www.lef.org/magazine/mag2010/nov2010_FDA-Delay-of-One-Drug-Causes-Lost-Life-Years_01.

shutdown did not affect the timeline for approval. The PDUFA decision date for sofosbuvir is December 8 or 9 depending on where you look. The overall tone of this document is very encouraging for a swift approval. As a genotype 2 hoping for the all oral treatment ASAP this is very good news. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/AntiviralDrugsAdvisoryCommittee/UCM371877.pdf?

Oh, and I also read that when TAF gets approved it will only be for HIV, similar to when TDF got approved at first (FDA approval for HBV came years later). You may be able to buy TAF 'off label', meaning your doctor may write the prescription so it will be legal for you to buy, but it will be hard to get any insurance company to pay for off label medication. I would think TAF in time will be approved for HBV too , just like Viread has.

Each drug trial and treatment requires an approval from the FDA, to the best of my knowledge. In that regard, the FDA so far as Vertex may approval a plan for treating naives, a separate plan for treating past TX failures, and I assume there is one for co-infected (HCV &HIV) as well. Right now there is a current trial for BID dosing, but approval will be based on 3X daily and at some point twice daily may see an additional application.

Vertex has begun the application process for approval with the fda. The process should be completed by the end of this year with approval coming shortly after that. The results are promising and I believe the fda is going to put it on the fast track for approval. My doctor told me 6 months ago it will be probably be ready by the end of 2010. Like pcds says though, there is no way to know for sure. It may be sometime in 2011 before it is available. Hang in there!

The secondary outcomes, such as hbvdna and HBsAg have not yet been announced. They have sFDA (China's equivalent of FDA) approval to conduct phase 2 and 3 trials. Still a way from getting sFDA approval as a new drug.

While you can get your insurance companies to approve the treatment it still has not been approved by the FDA for ovca and my guess is since the fda has pulled their approval for breast cancer, it may be unlikely approved for ovca. I just finished cycle 4 of Avastin and am considering a change to another treatment option. I have had dibilitating headaches from Avastin. As well, I feel like my body and mind are racing....very anxious.

Because of my persistence, I received three phone calls from the FDA today. I'm going to now present you with the clarity of what's about to happen with the "Rolling NDA" (New Drug Application) from Vertex and other pharmaceutical companies. A Rolling NDA is an application to have the FDA put this drug on a “Priority Approval” as opposed to a “Standard Approval”. Here's the difference.

it is rationale to use the most potent ones like tenofovir or entecavir all other patients had hbsag after first year so low that it may go on and clear even with no therapies, hbsag around 10-30iu/ml, one around 300iu/ml one patient, did not respond, this patient was on adefovir+lamivudine, non response may be due to the use of thee weaker drugs and who knows maybe using tenofovir or tenofovir+entecavir, anyway it is just one who did not respond and he will be able to retry interferon later o

Tenofovir fda approval

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