Monday, October 25, 2010

Vertex To File Telaprevir® FDA Application "Within Weeks"

I am surprised -- and happily so -- that the filing of the FDA New Drug Application is only weeks away, now. I was a little concerned that it would slip into 2011. Merck should be very chastened by this Telaprevir® news, by the way. Here is a salient bit of the Reuters reporting:

. . . .Vertex. . . said it plans to seek U.S. approval for the medicine [Telaprevir] in coming weeks. . . .

Telaprevir, from a new class of hepatitis C treatments, is an antiviral drug that is expected to compete with a similar medicine being developed by Merck, called boceprevir. But analysts have been virtually unanimous in their belief that telaprevir is the superior medicine.

Merck has completed phase III trials. . . .

No doubt. It is good to see the unanimity set in stone, by the MSM (as we've long foretold). And importantly, more than one analyst is now calling Telaprevir a $4 billion a year drug -- when it really gets rolling. It is, effectively, a cure for Hep C.


Anonymous said...

If telaprevir is approved as expected given its stellar results, do you expect:
1. Merck will have to go back for testing against telaprevir, or
2. Might boceprevir be approved as an "also-ran me-too" drug?

Condor said...

I do think Merck's Boceprevir will ultimately be approved by FDA, if for no other reason than it too has shown some good (but not nearly so good, as Vertex's Telaprevir) efficacy. The side-effects from Boceprevir are -- on balance -- worse than Telaprevir, and the data would suggest that the typical patient will need to stay on Boceprevir twice as long to acheive the same benefit (compared to Telaprevir).

I don't think Merck will run new trials, head-to-head.

I think Merck's best hope is to be a "me too" player now.


Condor said...

All of that said, there will be some patients who won't tolerate Telaprevir -- and a handful that may not respond to it (the 15 percent or so who've not seen a complete Hep C cure while on Telaprevir).

In those "outlier" cases, Boceprevir will be tried, as a second line of therapy.

Just my hunch.


Anonymous said...

I'm going to formulate my own project since you don't see any decent jobs you can get.

Could anyone provide any ideas or web sites as to how to find government grant money to begin with my personal business? I have already been looking via the internet but every single web site asks for money and I have already been told by the unemployment office to stay away from the websites that request cash for grant info because they're scammers. I would be truly grateful for any guidance.