Gilead submits TAF NDA for hepatitis B

[chihep]

Gilead Sciences (NASDAQ:GILD) files its New Drug Application (NDA) with the FDA seeking clearance of tenofovir alafenamide (TAF) 25 mg for the treatment of adults with chronic HBV infection. The company is transitioning its product line to TAF from TDF (tenofovir disoproxil fumarate) because it is just as effective at a dose less that one tenth that of TDF and is less stressful on the bones and kidneys.

The company intends to file its TAF Marketing Authorization Application (MAA) in Europe this quarter.

Previously: Gilead's TAF non-inferior to TDF in two late-stage HBV studies (Jan. 5)

http://www.medhelp.org/forums/Hepatitis-B/show/223

[needadvicewithhep]

I guess time will tell Stef :)

[stef2011]

this drug is tenofovir, nothing new, it just accumulates better in liver cells than other cells of the body (kidneys) so a lower dose can be taken and this is good for those with kidneys problems

very good drug but i d like to see if tdf is more potent than taf and zero resistance as tdf

[Sunny000]

When possible in Europe? My doc suggests treatment in the nearest future. Is it worth waiting ??

[Aduiski]

Not now but very soon in USA

[Cjb3695]

Is there a way for us to get TAF now?

[Jatashankar]

ya atleast we can live healthy with minimal harm from virus and drug both. 10 times lesser harm is 10 times more health!

[Aduiski]

while most of us awaiting a miraculous cure, this is fantastic news indeed.