Lemtrada (Campath) submitted for FDA and EU approval

[Marco]

Today, Lemtrada was submitted to the FDA and EU for approval. Lemtrada is another drug for the treatment of RRMS. I'll attempt to post a summary for Lemtrada a bit later (tomorrow?).

http://www.marketwatch.com/story/gen...sis-2012-06-12

That's really good news. It carries some definate risks, but seems very very powerful.

[TLC_31]

Lemtrada has been discussed here in recent months, including by those who have used the drug. It's had reported good results, but as with any drug there is no free ride. I wouldn't expect to make the switch for a year or two, if ever. Here are a couple of threads:

http://www.msworld.org/forum/showthread.php?t=119912
http://www.msworld.org/forum/showthread.php?t=109254
http://www.msworld.org/forum/showthread.php?t=112697

Also a wealth of information on Wikipedia and on this site:
http://www.msrc.co.uk/index.cfm/fuse...ow/pageid/1307

[Marco]

I am attempting to summarize what I know about Lemtrada. I have not been involved in the Lemtrada trials, have no relationship to Genzyme(Sanofi) or Bayer HealthCare and claim no medical (or any other) expertise. Please feel free to correct any mistakes.

MSWorld has a number of members that have first-hand experience with Campath.

What is Lemtrada?
Lemtrada (alemtuzumab) is an experimental oral drug for treating relapsing-remitting multiple sclerosis (RRMS). Other names for Lemtrada include Campath, MabCampath and Campath-1H.

Who makes Lemtrada?
Genyzme (acquired by Sanofi) in conjunction with Bayer HealthCare is developing Lemtrada. Sanofi is also developing an experimental oral drug, Aubagio (teriflunomide), for the treatment of Multiple Sclerosis (MS).

Is Lemtrada new?
The drug alemtuzumab was developed over 30 years ago and is largely used for the treatment of lymphoma and various transplants. Campath has been used minimally “off-label” to treat MS for a couple of years. “Off-label” simply means the drug is prescribed for an unapproved condition and is a common prescribing practice.

Is the drug approved?
On June 12, 2012, Lemtrada was submitted to the US Food & Drug Administration and European Union for approval.

How does the drug work?
Alemtuzumab attempts to interrupt the MS immune response by destroying certain T-cells. By selectively destroying the T-cells, Alemtuzumab reduces the damaging inflammatory process of MS. The specific antigen that Alemtuzumab binds to is called a CD52 lymphocyte.
Alemtuzumab is so effective at destroying T-cells that it can take the body years to fully replenish the eradicated T-cells. (Love the word eradicated).

Poor analogy: In a classroom, one student starts acting up until the entire class is disrupted. Removal of the student allows the class to return to a healthy learning environment. Similarly, Lemtrada’s goal is to remove only the cells that initiate the MS damage returning your body to a normal state of being.

How is Lemtrada administered?
Lemtrada is commonly administered via IV for five consecutive days and then three additional days a year later.

What were the Lemtrada trial results?
Lemtrada trials have largely been compared to Rebif. Lemtrada benefits compared favorably to Rebif ( widely believed to be the best injectible therapy for RMSS).
• Lemtrada when compared with Rebif reduced relapses by approximately 50-55%.
• There was also a 42% reduction in risk of worsening disability measured by EDSS.
• The reduction is disease progression was slightly better for Lemtrada patients compared to Rebif patients.
• On average, patients treated with Lemtrada had their disability rating decreased while those treated with Rebif had an increase in disability rating. In other words, Lemtrada REVERSED some of the MS-related disability. After two years, almost 30% of Lemtrada patients had experienced a six-month sustained reduction in disability rating (more than twice that of Rebif).

What about side effects?
Two significant side effects have been observed:
• Idiopathic thrombocytopenic purpura (ITP) that prevents blood from clotting and in rare situations can be fatal.
• Graves Disease where the thyroid becomes abnormal or overactive
Seven percent of patients developed a serious infection. Side effects to the infusion delivery method included mild to moderate reactions were common. Most other reactions were resolved with regular treatments and not considered significant.


What will Lemtrada cost?
Price information is currently unavailable and should be interesting.

Pontificating -> Campath’s effectiveness compared to injectible MS therapies could command a premium in the market place. Currently, Campath is cheaper annually than most other MS treatments. Would Genzyme be able to rename Campath (leukemia medicine) to Lemtrada (MS medicine) and increase the cost? Doctors could simply order Campath “off-label” and side-step higher drug pricing.


Will there be a financial assistance program?

There is no indication existing patient assistance programs would not be extended for this medication for those meeting program requirements.

[KateA2]

Thank you for posting this information in a condensed format...so very helpful!

Still, I totally fantasize about kicking my MS's heinie with a dose or two of Lemtrada...but I'm gamely plugging along a 5-month neub on Copaxone (and 6 months since dx) so no way would I be a candidate for this treatment - however willing I am to risk it. I've always been better at offense than waiting around, so to speak...DH calls it my "Field Marshal" or "300" temperament.

[spacedive]

Campath has worked for me. Last dose 3 years ago. No more pills no more shots...... for now.

When I was first diagnosed, I was so excieted to read about Campath. It's less talked about in the US as in the UK. Possibly because it's from the UK.

I think lemtrada sounds tastier, but Campath sounds so powerful and noble. I wonder why they changed the name?

[spacedive]

Maybe the name changed when Sanofi bought Genzyme. Their stock should go up when/if campath is FDA spproved. I don't know, maybe neru docs will only prescribe it if someones MS is running rampent. I know I risked a few things, but I did what I had to do to protect the things I love, like life.

It can give you other autoimmune diseases, so the risks must be weighed. Congratulations on it working for you.

[spacedive]

Thanks BigA. I know I'm not out of the woods yet the future is unknown for me because it is a trial. They continue to extract and test my blood once a month for over 3+ years now. I've been on a few extentions of the program, but it really is amazing since I was doing Rebif for years before the Campath 3X's a week. I believe I'm doing it for me and other people who want chance for hope.