Lemtrada Nov 14th 2014

[spacedive]

I heard last night at a meeting in St. Louis that Lemtrada may be approved Nov 14th 2014.

I think for some people this will be a major change in their life.

I wonder how many people are interested?

-Harold

[Mable]

Great news! I happen to have an appointment with my Neuro in late December. Did you give your testimony already, Harold? How did it go?

[spacedive]

I went last November to DC and this year I'm going back to DC in December, but I think the vote is in two weeks.

[bmrich]

That's great news! I thought we were going to have to wait for so much longer! Where did you hear this? I thought we wouldn't have it until next year.

[spacedive]

Went to a meeting of nureo docs in St. Louis and one of them said he was waiting and got an answer just before the meeting. I put this as a very strong maybe. They also talked about new mylen drugs. I'm thinking a route in the near future will be Lemtrada to stop/slow the MS and then mylen drugs for repair.

[Jules59]

Been WAITNG for Lemtrada

My neuro told me at the first of 2014 that he thought the drug would be approved in July 2014; when I saw him in September, he said they surely would approve it by end November 2014 and it should come out for distribution by early 2015. Don't know where he gets his info, but I have been waiting for it every since they took Campath off the market. I am going to pair it up with this abx therapy and see how it works...

[Myoak]

Lemtrada has FDA approval.

Google "Genzyme news" for articles.

Google "FDA approves once-a-year multiple sclerosis drug by Genzyme with warnings"

[Myoak]

A couple good articles:

http://www.bloomberg.com/news/2014-1...-treat-ms.html

http://news.genzyme.com/press-releas...a-approved-fda

If the links get shot down... Google, "Genzyme's Lemtrada Approved by the FDA".

[agate]

myoak, thanks for posting the links. I'm wondering about this (in the first article you've linked to):

Data presented at a meeting in September showed that 70 percent of those involved in the key clinical trials of the drug didn’t require any additional treatment after the first two years.

How can it be determined that a person wouldn't require additional treatment after 2 years? RRMS can come back as a relapse at any time. How can they be so sure that people don't require any more treatment with Lemtrada after 2 years? Is it too risky a drug to consider continuing on?

[spacedive]

Joy has come!

[Myoak]

Hi agate,

All they were trying to say is that at the end of two years 70% didn't need additional infusions.

Remember, Lemtrada is given in two sets of infusions; 5 days of infusions make the first set and one year later 3 days of infusions. No infusions between the first and second set (one year) and only if needed after the second year.

The article said after two years 70% needed no more infusions. Trials have been ongoing for over 4 years so they have data.

Some of the other 30% require 3 sets of infusions, some 4, and some 5.

The trials involved RRMS. Yes, a relapse could happen. If it does then another infusion would be considered, IMO.

Monthly blood and urinary monitoring is likely, IMO.

Sorry that I have limited time this weekend to provide greater detail. There are big risks and big rewards with Lemtrada.

Really an important addition to MS meds.

[69Mustang]

Long term Lemtrada out of the UK goes back 15 years, to 1999. This link posts the research to date on how people do over the long term:

Not every person has 15 year follow up data but I think the average was 8-10 years, so pretty long.

This is where the data comes from that most people need only the first two rounds.

There is a commenarty her as well if you don't want to read the research article.

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[msgijo]

69 mustang - Thanks! Just read your blog (I finally see that lemtrada is a possible treatment for me to argue for when I see my neuro in January, and figured that the more info I had the better my chances of getting him to listen...). Browsing thru some of the technical stuff I saw a reference to diabetes, and was wondering if you had any understanding of how the drug may affect a person with diabetes? Wouldn't it be great to have one drug take care of two problems?

But first things first. MS is the main reason that I am even looking at Lemtrada, and I would be happy to have the results that you got.

So many questions, but I just wanted to say Thank you and that I too believe the 69 'stang was the best ever built!