Wednesday, August 18, 2010

COMING SOON. . . Oral Meds for MS!!!

As most of you know there are currently no oral meds for MS. Like many others I inject my medication which you can read more about here.

I am fortunate that Avonex has and still is working well for me after almost 2 years. So the big question will be - do I stop using something that is working and try oral meds? This will have to be something I think about and talk over with my doctor once these meds become available. While I don't want to mess with a good thing (the Avonex working) I would prefer to stop doing shots and just pop a pill. . . .

For those of you interesting in learning more about the oral meds I've borrowed this info from the National MS Society website:

FDA Gives Priority Review Status to Application for Oral Cladribine to Treat Relapsing Multiple Sclerosis


Jul 28, 2010

EMD Serono has announced that the U.S. Food and Drug Administration has accepted and given Priority Review to its application seeking approval to market cladribine as an oral disease-modifying therapy for relapsing forms of MS. A Priority Review means that the FDA will review the drug in less than the usual amount of time. This designation is given to drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists. The goal for completing a Priority Review is six months from when the application is submitted, meaning that the agency’s approval decision could happen in December 2010, but it might take longer.

In a large-scale phase 3 clinical trial, cladribine tablets significantly reduced relapse rates and other disease activity in people with relapsing-remitting MS. Read more about this study.

In November 2009, EMD Serono announced that it had received a “refuse to file” letter from the FDA for its original cladribine application submitted in late September, which usually means that the agency deems the application incomplete. On June 8, 2010, EMD Serono announced that it resubmitted its application to the FDA for approval of cladribine.

Another oral therapy for MS, fingolimod (Novartis International AG), is currently undergoing final review by the FDA after an FDA advisory committee recommended that it be approved. The agency’s approval decision for fingolimod is expected in September 2010.


For those of you with MS will you try oral meds when they come out?

1 comment:

  1. Hi Jodi,
    I currently do not take any of the CRAB drugs for my MS, for a number of reasons. I will not be taking the oral drugs Gilenia or Cladribine when they come to market, mainly due to drug's side-effects, which in some cases have been serious, even lethal.
    Cladribine side effects include, low blood counts, fevers, increased risk of herpes virus.
    Gilenia's include, eye disorders, heart problems, infections, weakened lung function. Herpetic infections are seen with both drugs.
    Serious side effects occurred in at least 8.5 percent of patients taking Gilenia (in trials), compared with 5.8 percent of patients taking older multiple sclerosis drugs. There is little data on the long-term effects of using Gilenia.
    I am also not a big Pharma fan. It would be nice to see at least some of the projected profit(between $1 billion to $3.5 billion)that Novatris(Gilenia) will reap from the sales of this drug, go towards some research to find the cause and cure for MS. But that ain't gonna happen.
    Cheers,
    Karen

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