Efficiency of Antegren

OddDuck · Posted: Fri Nov 12, 2004 10:53 am Post subject:

I wasn't sure where to post this (or IF to post it), but I think I'll do it here.

When I wrote to the FDA with my concerns, I asked if they would be so kind as to just confirm receipt of my correspondence. I'm aware that the process they are in the middle of right now is highly confidential; therefore, I did not ask them specific questions nor did I press for information.

Well, just this morning I got confirmation from the FDA.

So, at the very least, they received it, and SOMEONE read it. That's all I was asking for.

It doesn't even matter if it was an automatically generated "response" or not. It's confirmation.

And I thank them for that. My faith in the FDA has just grown a hair.

Deb

HarryZ · Posted: Sun Nov 21, 2004 10:27 am Post subject:

The following post was taken from the MS Foundation Forum. Beyond the possible name change to Antegren, I found it interesting that the FDA might insist that NAB testing is required for Antegren users. I thought that I had read somewhere that NABs weren't an issue with Antegren but it appears they very well may be.

Harry

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I went to the Texas Annual Meeting and Research Symposium today. Dr Edward Fox the medical director for the South Texas Chapter was one of the speakers. He got approval from the FDA to go ahead and give us an update on antegren. He was leaving the symposium to go to a lead researcher meeting on it.

He said the FDA has required them to change the name. It's name is too close to another drug and he doesn't know what the name will be. He is HOPEFULL and they are expecting it to be approved by the FDA this Tuesday, before Thanksgiving.

He still has questions about the insurance, but thinks that this will all be worked out in the next few months. They will have a hard time disallowing it because their data shows it to be at least 60% effective in reducing relaspes.

He said that 6% of people on it will develop neutralizing antibodies to what is now knowned as antegren and they will know as soon as 3-6 months, who those people are and they will have to be taken off. Because of the expense, people on this medication will have to be tested for this, but they are not sure who will do the testing.

The data looks good for short term but he couldn't say how it will work long term.

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batpere · Posted: Wed Nov 24, 2004 7:54 am Post subject: no benefit to tysabri + avonex?

Let's decipher the announcement.

66% reduction tysabri vs placebo
54% reduction tysabri+avonex vs placebo+avonex
.66 * .54 = .37

1 - .66 = .33

Is tysabri+avonex even less effective than tysabri alone?
Or would this not be statistically significant? It would after
all be from different patients.

Or am I flunking this story problem?

MeadowStream · Family Member Joined: Oct 18, 2004 Posts: 58

batpere,

I think the Sentinel data is a little confusing. The placebo IS beta interferon and the 54% reduction is Antegren (Tysabri) relative to beta interferon.

The Affirm data shows 66% reduction - Antegren (Tysabri) v. true placebo.

Furthermore, the Sentinel data is slightly confusing because the patient population is select: patients who have experienced exacerbations while already being treated with beta interferon.

Hope this helps,

MS