ANYONE ON LEMTRADA?

[regi girl]

I AM CURRENTLY ON TYSABRI AND I AM JCV+ WITH A RATHER HIGH TITHER NUMBER. MY NUERO WANTS TO PUT IN ON LEMTRADA AS SOON AS IT IS APPROVED. I'VE BEEN READING UP ON IT BUT I HAVE FOUND THAT WHAT YOU READ BEFORE IT'S APPROVED AND WHAT IT'S REALLY LIKE CAN BE TWO DIFFERENT THINGS. DON'T MEAN TO SOUND NEGATIVE BUT IT'S JUST VERY IMPORTANT TO MAKE GOOD INFORMED DECISIONS WHEN IT COMES TO FIGHTING THIS DISEASE.

SO MY QUESTION IS, IS THERE ANYONE OUT THERE WHO HAS BEEN IN THE CLINICAL TRIALS? IF SO, WOULD YOU PLEASE SHARE YOUR EXPERIENCE WITH THE DRUG, GOOD, BAD OR OTHERWISE.

THANK YOU ALL FOR HELPING ME, I APPRECIATE ANY FEEDBACK I CAN GET.

[Michela11]

I'm not on Lemtrada but am considering it when it goes on the Australian PBS next year.

I found this site great, from David, who's now 10 years post treatment.

http://www.davidscampathstory.org/experience.html

[Michela11]

Hi, I posted a link to a site that I found very helpful but now realise it probably won't appear here.

I've put the link in my profile.

A man called David had Campath (Lemtrada) treatment more than 10 years ago and he's detailed his story and experiences up to this point.

[JerryD]

I am happy to hear that there is some real compassion left in the world of big 'pharma'. Of course, David's treatment was probably paid for with public funds. It appears that Lemtrada stops disease progression. Got to be better than the current DMD's that are no better than a 'band-aid'.

[Michela11]

The worst thing though, is the company pulling Campath off the market, rebranding it and attempting to profiteer.

I understand the companymis about "business" and "profit" but come on!

Hopefully this link works here. If posted already, many apologies.

http://www.pharmalive.com/sanofi-ang...campath-progam

"Last summer, Sanofi's Genzyme unit attempted to navigate a tricky and potentially explosive situation. The drugmaker publicly disclosed plans to withdraw its Campath medication for leukemia from some 60 markets, including the US and the European Union, in hopes of eliminating off-label use to treat multiple sclerosis.

Why? A lower-dose formulation to be called Lemtrada is awaiting regulatory approval for multiple sclerosis, and analysts expect the drug to generate up to $400 million by 2016 for this particular indication. By comparison, Campath last year delivered $76 million in sales, according to The Pink Sheet.

Anticipating criticism that its move was motivated purely by profits, Genzyme instituted a program that offers Campath, which can cost up to $60,000 annually, to leukemia patients free of charge under a patient access program. But the drug is being made available to treat multiple sclerosis patients only through clinical trials, and some UK doctors are furious.

In their view, the move is designed to eventually migrate multiple sclerosis patients to a much more expensive drug. Although Genzyme has not disclosed planned pricing for Lemtrada, a few prominent neurologists last week wrote the UK health minister over concerns that the medication may cost up to 20 times higher than Campath and that patients are being harmed. For MS patients, only a few injections per year are needed and can cost about $5,000. The decision has "serious implications for vulnerable UK patients with MS," because patients who have already started treatment with Campaith will "not be able to get their vital second course." Meanwhile, newly diagnosed patients may "miss their window of therapeutic opportunity" to start treatment, putting them at risk of "progressive, severe disability."

The maneuver, they continued, established an "inappropriate precedent," and "shows little regard for patients whose opportunity to alter the course of their disease is time-limited, and may represent an over-enthusiastic attempt by the parent company to profit from the current situation."

The letter, which was reported by The Independent, was sent by Neil Scolding of the University of Bristol, Neil Robertson of the University Hospital of Wales and John Zajicek of the University of Plymouth. In an e-mail to us, Robertson confirmed the contents of the letter, but declined to further discuss his concerns until the health minister replies.

However, Zajicek told the paper he has treated about 150 patients with the drug, and up to 500 in the UK have received it. "Many of us think it is the best drug for patients with aggressive MS in the early stages of the disease. It's the greedy behavior of the drug company that upsets me," he said. "They are just trying to rebrand it and put the price up. It is morally corrupt."

Their sentiment was shared by Doug Brown, who heads biomedical research at the Multiple Sclerosis Society in he UK. The drug "shows real promise as a potentially new medicine for many people with relapsing-remitting MS. There is no good reason why people with MS who have been allowed to benefit from the treatment should now be denied it. "Genzyme needs to come up with a scheme, quickly, that makes their product available to all those people currently being treated and, if it's licensed, price the drug reasonably so it is deemed cost effective" on the UK's National Health Service. A UK Health Department spokesman told the paper the agency is working with drugmaker to ensure access.

The publicity may undermine the carefully calibrated transition to Lemtrada. A Genzyme spokesman writes us that the patient access system established to provide the drug to leukemia patients is the same in each country, but he declined to say how long the program will last.

"We have worked with health authorities globally to establish Campath access programs and are committed to ensuring that patients who need the product will receive it," he wrote. "...We intend to provide Campath through the access program for the foreseeable future. We will review the program periodically to determine if modifications are needed or a new direction is warranted."

So far, the US program seems to be working for leukemia patients. Hildy Dillon, a senior vp of patient services at the Leukemia and Lymphoma Society, tells us that she is not aware of any difficulties that physicians have had in obtaining the drug for their patients. She adds that Genzyme did not indicate a plan "to discontinue the program... They told us they did not have any immediate plans to set a date at which this would end."

She acknowledged, however, that some leukemia patients may experience difficulties if the drug were not available or easily accessible, because different people respond differently to varying medications. "Whether there would be another option for a patient" in the event Campath is not available, she tells us, "would have to be determined by a physician and the kinds of therapies available and the condition of the patient."

But Til Menge, a neurologist at University Hospital Dusseldorf, recently told BioCentury that the Campath safety profile should mitigate off-label use, especially as additional clinical trial data for Lemtrada is released. "Given the known safety profile of alemtuzumab, I think MS doctors will be reluctant to use it off label,” he said.

The publication noted tha the Campath label carries a boxed warning about the risk of cytopenias, infusion reactions and infections. In a Phase III trial in 147 treatment-naďve patients, 97 percent reported grade 3 or 4 lymphopenia and 42 percent reported grade 3 or 4 neutropenia (see here).

[UPDATE: John Zajicek of the University of Plymouth sent us this note after reading our post and the comments. He writes this: "First, Campath is a drug developed in Cambridge UK, many of us have experience of using it for more than 20 years. The UK, therefore, has much more experience of using the drug than anywhere else in the world. Two, the problem with other drugs used to treat MS is that when you stop using them the disease comes back (maybe worse than before). Three, we need to be careful, but the side effects of Campath are so far they are manageable provided that patients are managed in centres used to the drug. The profile of side effects in young people with MS is very different to licensed use. Four, the company are trying to increase prices for MS, but provide it cheaply for leukemia."

[regi girl]

THANK YOU SO MUCH, MICHELA11, THE LINK AND THE OTHER INFO YOU GAVE ME WAS SUCH A BIG HELP. IT SOUNDS PRETTY PROMISING TO ME.

I'M SORRY I HAVE NOT REPLIED SOONER TO YOUR POST BUT I WAS OUT OF TOWWN LAST WEEK. I WENT ON VACATION TO THE BEACH, AND IT WAS WONDERFUL. IT WAS THE FIRST TIME IN ABOUT 3-4 YEARS I WAS ABLE TO WALK ON THE SAND TO THE OCEAN WATER. I WAS ABLE TO RENT AN UNBRELLA AND CHAIRS AND I DUG MY TOES IN THE SAND. IT WAS GREAT AS I LOVE THE BEACH AND THE OCEAN, IT'S ONE OF MY FAVORITE THINGS. TYSABRI HAS GIVEN THAT BACK TO ME.

I ALSO DID NOT LOOK AT A COMPUTER SCREEN FOR NINE WHOLE DAYS. I HAVE OPTIC NERVE DAMAGE, AND MY JOB CONSISTS OF CONSTANTLY BEING ON THE COMPUTER, I GO HOME EVERY NIGHT FEELING AWFUL. DOUBLE VISION, HEADACHE, SEVERE DIZZINESS AND VERY IMPAIRED VISION. THIS HAS REALLY SHOWN ME THAT I MUST LEAVE MY JOB. I'VE BEEN SAYING THAT FOR THE LAST YEAR BUT I'VE BEEN STAYING JUST A FEW MORE MONTHS AND THAT HAS LEAD NOW TO ANOTHER YEAR. BUT THIS TIME I AM OUT OF HERE, DECEMBER WILL PROBABLY BE MY LAST MONTH, I'M VERY SCARED AND THIS PUTS MORE STRESS ON ME.

I HAVE SO MANY HARD DECISIONS TO MAKE IN MY LIFE. I HOPE LEMTRADA IS GOING TO BE AN IMPROVEMENT IN MY LIFE.

IF ANYONE ELSE HAS AN EXPERIENCE WITH LEMTRADA OR KNOWS OF SOMEONE WHO HAS, PLEASE SHARE WITH ALL OF US. I'M VERY INTERESTED TO KNOW OF THEIR EXPERIENCE WITH THIS NEW DRUG.

THANK YOU FOR LISTENING MY DEAR MS FAMILY.

[spacedive]

campath

I'm on campath going on 5 years now.
The entire time including now no active lesions.

Had one recent relaspe, but doing anther dose Tuesday.

[Ms_M]

@spacedive

... can you please message me re. your doctor and the country you are located in?


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[MSer102]

I'm on campath going on 5 years now. The entire time including now no active lesions.
Had one recent relaspe, but doing anther dose Tuesday.

spacedive are you in the clinical trial? I'm thinking you must be because apparently the manufacturer has pulled Campath off the market (at least in the US) in anticipation of it being approved as Lemtrada so nobody else can get it right now. If you aren't in the clinical trial do you know how your doctor is still able to get it for you?

[regi girl]

Lemtrada & Fatigue

Thank you Spacedive for your input, I was wondering how and if it has helped your fatigue?

I have been on Tysabri for a year and it has really helped with the fatigue. They have now put me on 8 week intervals with my Tysabri since my jcv number is high. I'm 7 weeks out since my last infusion and I'm feeling really bad. I forgot how bad this gets.

I just pray that the Lemtrada can keep me where I am on Tysabri. Also I can't find much info on anyone who is on Lemtrada,except for you and the blog that was posted, I would like to hear their personal story.

If anyone has anymore info I would really love to hear from you.

Thanks

[durgastiger]

Lemtrada in Uk

Hasn't the FDA in UK made is accessible to the public ? When will the U.S. FDA make it accessible to the public.

[Michela11]

Not sure about FDA in USA.

TGA in Australia is expected to give it the tick in the middle of 2014

[MSer102]

When will the U.S. FDA make it accessible to the public.

The FDA has accepted the manufacturer's supplemental Biologics License Application for Lemtrada but hasn't set a review date yet. So there's no way to know when they will approve it.

Hasn't the FDA in UK made is accessible to the public ?

Well, not exactly.

First, the initials "FDA" apply only to the US Food and Drug Administration. The UK doesn't have an FDA. They also don't have their own agency that acts in quite the same way as the US FDA. The UK is part of the European Union so they follow what the EU does.

It was the European Medicines Agency (EMA) of the EU that just approved Lemtrada. Almost every country in Europe belongs to the EU so doctors all over Europe (including the UK) can now prescribe Lemtrada. BUT in countries that have "socialized" medicine - like England - medicines are paid for by their national health service. So people can't get medications through their medical insurance until the national health service decides to provide them. The last article I read said that England's NHS hasn't decided yet whether to cover Lemtrada. So until the NHS decides to provide Lemtrada, even though it's approved and "legal" it isn't "accessible" to the "public" in England - meaning anyone who gets their medical care through the NHS.

[Myoak]

Hi Regi girl,

There is a fascinating video on Lemtrada you can find by Googling "Cambridge University video The Story of Campath-1H".

I would post the quick click link but the mods shot down my previous two youtube links (presentations at the NIH by Dr. Bert Berkson) so you may as well take the long route and enter the title into search at Google.

The video is a great presentation of how Campath (Lemtrada) was developed but it also gives insight into issues related to taking it.

The video is about 31 minutes and is especially fascinating in the 20-24 min area.

I wish everyone who is contemplating NOT treating their MS would take the time to view this video to understand why early treatment is critically, critically important to future well-being.

Best to everyone! And, Happy Birthday to you Regi, may good health follow you, overtake you, and lead you to a life more flourishing than any you have ever dreamed of.

Regi, of course the Phase 3 trials of Campath (Alemtuzumab) can be Googled and read, especially look at results and conclusions.

Campath has been approved in the EU. It hasn't been priced yet, there. I read more and more opinions of approval before the end of the year in the US. Just have to wait and see. In any case, it will not be long, I believe.

[Myoak]

This link indicates the pricing for Lemtrada in Germany will be $95,000. That would make it about $11,700 per vial; I believe treatment is by 5 infusions beginning treatment and 3 more at 12 months for a total of 8 vials. If the story is accurate pricing will likely to be similar once approved in the US, IMO.
http://www.firstwordpharma.com/foote...#axzz2gpCqx7IN

In 2012 firercepharama reported, “Campath for leukemia treatment runs $60,000 per year in the U.S. MS patients need a fraction of the cancer dosage, and so under that pricing scheme, the drug would cost just $6,000 per year.”
The same amount of Campath (Lemtrada) costing $6,000 for leukemia will cost $95,000 for MS if pricing is similar in the US and Germany.

Sanofi pulls Campath to clear way for higher-priced Lemtrada - FiercePharma http://www.fiercepharma.com/story/sa...#ixzz2jDIAZEHW


Lemtrada was approved in Europe last September as reported by the link below.
http://www.marketwatch.com/story/eur...mab-2013-09-17