ANYONE ON LEMTRADA?

[regi girl]

Thanks Myoak for the posts, my eyes have had it for the day so I hope to read these posts later tonight or tomorrow.

The pricing is unbelievable. But I think we all figured it would be like that.

I was wondering if the government shutdown would delay the approval process, I haven't been able to find anything to indicate a new release date. I continue to read that the anticipated release date is sometime in mid December. If anyone has read anything different please pass it on.

I am getting closer to the 18th infusion of Tysabri, my nuero is trying not to go past the 18th infusion mark.

Fingers crossed.

[Myoak]

You are welcome regi girl. The links are general interest but the youtube video “Cambridge University video The Story of Campath-1H" is more specific about Lemtrada as a treatment.

Please keep in mind that I’m not advocating for Lemtrada but only providing information. It seems you are doing well on Tysabri. PML is a risk but active MS is a huge risk to well-being, also. You have the risk of PML with Tysabri but you apparently enjoy better health because of Tysabri. Treatments decisions are so difficult in MS; often comes down to best guess. Most MSers struggle making treatment decisions so you have lots of company.

Best to you whatever course is taken.

[Myoak]

FDA panel supports approval of Sanofi MS drug Lemtrada

http://uk.reuters.com/article/2013/1...9AC18820131113

“A federal advisory panel recommended approval of Sanofi SA's experimental multiple sclerosis drug Lemtrada on Wednesday, but said the drug should be reserved for patients who have failed other therapies."

"In a surprise decision, an advisory panel to the Food and Drug Administration voted 14 to 0, with one abstention, that the drug should be approved despite its potential to cause cancer and other serious conditions.”

"The FDA is not bound to follow the advice of its advisory committees but typically does so."

[Myoak]

There is a great deal of speculation about FDA approval of Lemtrada. Little wonder given the confusing votes taken so far. My guess is that it is very likely the FDA will approve Lemtrada but possibly not as a first line treatment. Only my opinion.

Differing opinions are certainly understandable. I could easily be wrong. However, since patient testimony at the hearing was incredibly strong and MS treatment options are pretty limited I believe the FDA will approve but perhaps not as first line therapy. Have to wait and see.

If you care to read the FDA Report here is the link. It takes awhile to download because it is 370 pages.

http://www.fda.gov/downloads/Advisor.../UCM374186.pdf

There are differing takes on possible approval, to be sure.

[spacedive]

Lemtrada

I went to the FDA meeting in Washington DC, spoke to them along with about 8 other people. The committee voted 17-0 in favor of Lemtrada.

Lemtrada has been worth it for me. It's no walk in the park for the infusion, but 1.5 weeks later I feel like superman.

-spacedive

[Myoak]

Hi Spacedive,

Thank you for sharing your experience. It is wonderful that Lemtrada has benefitted you and you were willing to testify.

A Nov 16 story in the Boston Globe provides some help understanding the series of votes taken by the FDA advisory committee. Please keep in mind that the Nov 13 meeting was an advisory committee, not the FDA officials who will rule on permitting Lemtrada to be sold in the US.

http://www.bostonglobe.com/business/...QcN/story.html

Quoting the Boston Globe:

“An inconclusive series of votes by a medical advisory panel could prompt US regulators to delay deliberations and demand further work from Genzyme before deciding whether to approve the Cambridge biotech’s multiple sclerosis drug, Lemtrada, once seen as key to its future.
In a series of votes at the end of the advisory committee meeting, the panel sent mixed signals to FDA officials who will rule on whether Genzyme, owned by French drug maker Sanofi SA, will be permitted to sell Lemtrada in the United States.

The agency has not said when it will make a decision, but analysts had been anticipating one by the end of the year.

The advisers, in an 11-to-6 vote, accepted the view of FDA staff that there was “bias” in the clinical trials because Genzyme didn’t keep patients from knowing whether they were taking Lemtrada or a rival drug, Rebif, which is marketed by EMD Serono of Rockland.

But the committee, on a 12-to-6 vote, said Genzyme nonetheless provided substantial evidence that Lemtrada worked for patients with relapsing MS. And by a 17-to-0 vote, the panel concluded that Lemtrada’s safety concerns shouldn’t preclude its approval for patients for whom other drugs aren’t effective. At the same time, it voted 16-to-0 to recommend that Genzyme’s drug should not be allowed for sale in the United States for use by newly diagnosed MS patients. (Some panel members abstained from a number of the votes.)” End Quote

Still a bit of guessing if Lemtrada will be approved (by the FDA agency following advice from the Nov 13 meeting of the advisory panel), and if so when, and under what conditions. One analyst said, “We’ve seen instances when the FDA delays approval of a product until a company presents a risk evaluation and mitigation strategy.”

The FDA has not ruled on Lemtrada, yet.

Also, there was another post on this thread which expressed an opinion that the FDA may not approve Lemtrada. That is an entirely legitimate opinion! Although I disagreed I was so sorry to see the post rescinded, perhaps by the poster. Please know that your opinion is worth mine and more. We all learn as we share thoughts with each other so keep posting! My most humble apology if I was overbearing to the point where someone would withdraw their comment.

God Bless you and thank you for sharing.

[Thinkimjob]

I'm booked in for Lemstrada/ Campath in June in Brisbane, Michela11. Anything that does something to stop progression has to be worth it.
Usually our PBS follows the US FDA.

[Michela11]

I'm booked in for Lemstrada/ Campath in June in Brisbane, Michela11. Anything that does something to stop progression has to be worth it.
Usually our PBS follows the US FDA.

Good one! And big news it's finally approved in Australia. I so want to give this a go. Best of luck

[regi girl]

I'm sooo happy for you!! I hope you have good luck with this new drug. I wish we had it here in the U.S.

[69Mustang]

I just heard the Pharm board is blocking Lemtrada in Australia- is this true?

[_Angel_]

Has anyone heard what's happening with Lemtrada in Australia or when it might go on the PBS?

[Elliejah]

Has anyone heard what's happening with Lemtrada in Australia or when it might go on the PBS?

Was with my Neuro about 3hrs ago and he said Aus should be good for Feb/March provided it's approved by PBS/ect.

[shalimar]

is these injections given every year or only once in a lifetime?

[Mable]

Shalimar, they're infusions. You take one a day for five days. Wait a year and take one a day for three days. Then, you don't do another infusion unless the disease pops up again. Some people never do any more. Some have had to repeat the 3-day course a third, fourth, or fifth time.