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Siponimod Approved (Mayzent tablets)

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    Siponimod Approved (Mayzent tablets)

    The U.S. Food and Drug Administration today approved Mayzent (siponimod) tablets to treat adults with relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

    https://www.fda.gov/NewsEvents/Newsr..._source=Eloqua
    PPMS for 22 years (dx 1998)
    ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

    #2
    Thanks KoKo - just saw this on the morning news. Here's another article - https://www.biospace.com/article/nov...-drug-mayzent/

    It's for RRMS and also SPMS with decease activity (does that mean SP with relapses?) Cost is $88,000 per year!!
    1st sx '89 Dx '99 w/RRMS - SP since 2010
    Administrator Message Boards/Moderator

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      #3
      Originally posted by Seasha View Post
      Thanks KoKo - just saw this on the morning news. Here's another article - https://www.biospace.com/article/nov...-drug-mayzent/

      It's for RRMS and also SPMS with decease activity (does that mean SP with relapses?) Cost is $88,000 per year!!
      Seasha

      Yes, active SPMS is described as having relapses or evidence of new MRI activity.

      From the NMSS:

      SPMS can be further characterized at different points in time as either active (with relapses and/or evidence of new MRI activity) or not active, as well as with progression (evidence of disease worsening on an objective measure of change over time, with or without relapses) or without progression.
      PPMS for 22 years (dx 1998)
      ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

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        #4
        Silly me - I knew that. That's what I get for hastily posting within 15 min of waking up and not having my morning coffee! I even spelled disease wrong! lol
        1st sx '89 Dx '99 w/RRMS - SP since 2010
        Administrator Message Boards/Moderator

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          #5
          MSRP is $88,000 before negotiated insurance discounts. Of course qualifying patients will be eligible for marketing assistance programs.

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            #6
            Originally posted by Seasha View Post
            Silly me - I knew that. That's what I get for hastily posting within 15 min of waking up and not having my morning coffee! I even spelled disease wrong! lol
            It's all good, Seasha!

            I'm sure there are members who were not aware of the newest definition of SPMS, since the changes were made.

            Knowledge is power.
            PPMS for 22 years (dx 1998)
            ~ Worrying will not take away tomorrow's troubles ~ But it will take away today's peace. ~

            Comment


              #7
              Originally posted by Seasha
              Cost is $88,000 per year!!
              Which makes perfect sense, doesn't it?

              After all, given that Ocrevus is something like $67,000/year, we cannot expect a newer drug to come out and be cheaper, can we? Think of the poor Novartis shareholders!
              59M / RRMS / Dx1987 / Ocrevus

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                #8
                New meds, especially orals, are welcome additions!

                Mayzent was approved to treat CIS, RRMS, and SPMS.

                Mayzent® (siponimod) is tweaked Gilenya (fingolimod).

                The patent is running out on Gilenya so there was a push for a patented replacement. Plus, there are some significant side effect issues with Gilenya that Novartis attempted to solve with the new formulation, Mayzent.

                Only time will tell but the hope is that the new drug will have less onerous side effects than the Gilenya. Those taking either med should verse themselves in possible side effects, IMO.

                Mayzent “cut the annual relapse rate by 55 percent and showed reduced disease progression to about 26 percent at six months.” Also, Mayzent “resulted in a 23 percent reduction of brain volume loss.”

                As a reminder, in trial, 1200mg a day of lipoic acid resulted in a 66% reduction of brain loss volume (blv) in SPMS, compared to Mayzent’s 23% reduction of blv.

                Also, lipoic acid is not known to cause the macular edema, nor hypertension, which occasionally occur using Gilenya or siponimod.

                Good quality lipoic acid costs in the low hundreds per year and requires little monitoring; Mayzent is priced at $88,000 and requires a great deal of monitoring.
                Something to think about, I guess.

                I believe Mayzent has a great chance of being the most effective oral. But I question if that is saying a lot. Balancing disease effectiveness and side effects, the orals seem weak compared to Tysabri, Ocrevus, or Lemtrada, IMO.

                However, another new oral on the horizon, cladribine, appears to have far fewer side effects than any other MS med, oral or injectable.

                If Mayzent proves to decrease some of the side effects in real world use seen with Gilenya, it will be well-received... which is good news!

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                  #9
                  I will not take this medication and will refuse it. not taking something that mess with your heart.
                  DX 2017/Tecfidera/Ocrevus 2019

                  Comment


                    #10
                    I appreciate all of your posts ! This is exactly the type of discussion that I hope to find on this board ! Thank you all ! Good luck !

                    Comment


                      #11
                      It is difficult to have much confidence in Novartis which makes both Gilenya and Mayzent.

                      Novartis agreed to pay a $422 million dollar fine in 2010 for a kickback scheme in which they paid doctors to prescribe their meds. Again in 2013 Novartis agreed to pay a fine of $390 million for a scheme involving kickbacks to specialty pharmacies. And, two days ago a Federal judge ruled Novartis must face a lawsuit involving kickbacks filed by a whistleblower and the government.

                      As far as I know, none of the kickbacks for which they paid heavy fines involved MS drugs so hopefully our treating neuros in MS played no role. However, a repeated pattern of illegal behavior by Novartis is concerning and tends to cast doubt about how trustworthy their products are.

                      I urge those considering Gilenya or Mayzent to truly examine those MS meds and read available online information about them. Although recognizing they may be a good fit for some, I personally would not take them nor would I want a loved one taking either. JMHO.

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                        #12
                        Read about side effects. Do you really want take f you have that will mess with your heart, eyes and have to have multiple heart tests, check if you have chicken pots vaccine and serval other test before you take it and get regular testing done. I have no faith in this drug. Its gilenya but worse version.
                        DX 2017/Tecfidera/Ocrevus 2019

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                          #13
                          As someone who started taking Mayzent i will say the testing beforehand was not that bad. I did have an EKG, EEG and eye exam. All that are probably good to have on file anyway for future reference. The eye exam was part of my yearly check up anyway and EEG was done right at my neuro office. EKG was done right at my PCP office. There was some blood work as well but a visiting nurse came to my house and it took 10 minutes. Visiting nurse could also do the EKG.

                          Everyone has a right to what they want to take and should do what is comfortable. Only speaking to the work up for the medicine was not that bad in my opinion. I also feel less nervous being on it than i did with Tysabri due to the PML as i was JC +.

                          Again, everyone has different comfort levels and opinions. Just ask me again in 6 months how i feel about it
                          Dx March 2018; possible first episode: August 2011
                          Tysabri May 2018-June 2019, Mayzent July 2019

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                            #14
                            Originally posted by Jennaly16 View Post
                            .
                            Just ask me again in 6 months how i feel about it
                            I will, if I can remember! I just had an appt with my new neuro and she casually mentioned that I might want to look into this med. However, it was confusing to me, as I don't have "active" SPMS which I assume this is designed for.

                            Let us know how it goes, Jennaly!
                            1st sx '89 Dx '99 w/RRMS - SP since 2010
                            Administrator Message Boards/Moderator

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                              #15
                              Hey all!

                              Update- almost three weeks on Mayzent and it's the best i've felt in a while. I did have headaches occurring almost daily. Nothing that kept me down but enough to take some Ibuprofen.

                              I actually went away this weekend and did some walking, shopping, hanging outside, touring and just constant moving in the horrible, hot weather. I didn't get the fatigue i used to get and wasn't down and out the next day. I even was able to enjoy a few alcoholic beverages while i couldn't do on Tysabri (for whatever reason one drink on Tysabri made me completely dehydrated and i would fall).

                              I know it's new and only time will tell but this weekend i actually said it was the most normal i've felt since being diagnosed! I'll check back though to update as it's still early on the medicine.

                              Going to knock on wood now
                              Dx March 2018; possible first episode: August 2011
                              Tysabri May 2018-June 2019, Mayzent July 2019

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