MS Medications Pending FDA Approval in 2010

For those who might be interested, from the NARCOMS Newsletter at http://www.cmscnarcoms.org/files/NARCOMS_Newsletter_2_Jan2510.pdf

Approved for symptoms:
DALFAMPRIDINE (Ampyra) – On January 22, 2010, FDA approved dalfampridine (Ampyra) a sustained-release oral tablet, to improve walking in patients with MS. Dalfampridine blocks potassium channels on the surface of nerve fibers, which may improve the conduction of nerve signals through areas of demyelination. In higher dosages, there is some risk of epileptic seizures.

Potential DMDs:

CLADRIBINE - is an FDA approved chemotherapy treatment most often used to treat leukemia and lymphoma. It provides immunomodulation through selective targeting of lymphocyte subtypes. A Phase III study reported in the New England Journal of Medicine, January 20, 2010 (www.nejm.org), showed significantly lower annualized relapse rate, higher relapse-free rate, lower risk of progression of disability and significant reduction in the brain lesion count on magnetic resonance imaging (MRI) compared to placebo.

FINGOLIMOD (FTY720) - is the first of a new class of potential MS medications which appear to induce immune cells to remain in the lymph nodes and spleen rather than migrating into the brain and spinal cord. Recent studies, published in the New England Journal of Medicine, January 20, 2010 (www.nejm.org), showed significantly lower annualized relapse rates compared to both intramuscular interferon beta-1a and placebo. However, at higher dosages, two fatal infections occurred. The benefit to risk factor of Fingolimod is still being researched.

LAQUINIMOD - a once-daily oral therapy, is now being studied in two Phase III clinical trials. It received Fast Track designation from the FDA in February, 2009. To this point, laquinimod has been well-tolerated and no severe side effects have been observed. Laquinimod may be available on the market as soon as late 2011.

TERIFLUNOMIDE - also a once-daily oral therapy, demonstrated beneficial effects in MS patients in Phase II and is now in Phase III. An immunomodulatory drug, Teriflunomide inhibits rapidly dividing cells, including activated T cells, which are thought to drive the MS disease process.

BG-12 (dimethyl fumarate) - is another emerging oral therapy for MS. BG-12 has been shown to activate the Nrf2 transcriptional pathway. This pathway is thought to defend against oxidative-stress induced neuronal death, protect the blood-brain barrier, and support maintenance of myelin integrity in the central nervous system – all key elements to treating MS. Now in Phase III clinical trials, BG-12 could soon be headed to the FDA for approval.

PS If you're not signed up for the NARCOMS MS patient registry, it's an easy way to contribute to MS research. All you have to do is answer a survey online or by mail a couple times a year. Sign up at http://www.cmscnarcoms.org

Benefits of Participation

    * You are helping to provide the information needed to learn about the variations of MS in a very large group of patients and to monitor the progression of the disease
    * You help us monitor the effects of various treatments. Your information may be providing ideas for future research
    * You will be receiving the printed version of the MSQR free of charge
    * You will be informed of recent studies and their results
    * You will be notified of clinical trials in which you may be eligible to participate

[truelove47]

Thanks sho

Maybe 1 of these oral drugs is a drug that my neuros P.A. was eluding to that would be comming out on the market in 2010 or 2011.

I was telling her that I could not stand being on avonex anymore.

Thank you  Linda

[Lulu54]

Sho makes a good plug here for registering - please help this group increase its database.  The work they do with this information is essential to MS care.

be well,
Lu

[shoshin]

Hopefully, with that many drugs in the pipeline, at least one will get approved fairly soon. I think there is pressure on the FDA to approve these drugs quickly since there is a strong need for better MS treatments.

I saw on another thread you were asking about immunosuppressants after cancer. I don't know anything about whether that's a good idea or not, but I wanted to reassure you that the CRAB drugs (including Avonex) are immunomodulators and don't suppress the immune system. As I understand it, immunomodulators just change the way the immune system works in some way; they don't suppress it.

However, most (maybe all?) of the new oral drugs are immunosuppressants. I was in a trial for FTY720/fingolimod, which is definitely an immunosuppressant and my WBC went through the floor while I was on it. My PCP was thinking about AIDS. So if you're concerned about immunosupression, you should definitely bring that up with your neuro before switching.

The oral drugs are not likely to be cheaper, but they are definitely more convenient. They seem to be more effective than the CRAB drugs, but they also have worse safety profiles. So switching is not necessarily straightforward.

In the 18 months I was on FTY720, I only remember being sick once and that was in the early fall last year. Since I've been off of it (2 1/2 months), I think I've been sick three times. In fact, I'm home sick today. I don't get that, but there it is.

One of the potential side effects listed on the trial consent was more infections and colds. When I was getting out of the trial, the head neuro asked if I had gotten sick more and I said no. Interestingly, he said they were finding that many people in the trial weren't getting sick more often and that the immune system still seemed to be able to activate enough. Scarily, PML was also on the consent form, although there have been no cases with FTY720 and legally, I'm sure they want to cover themselves. But that is another potential fallout from immunosuppression.

I wish there were easier answers.

sho

PS Lulu is right--sign up for NARCOMS if you're not already.