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Thread: Siponimod approved...called Mayzant now...SPMS drug

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    Distinguished Community Member Lazarus's Avatar
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    Default Siponimod approved...called Mayzant now...SPMS drug

    The US Food and Drug Administration (FDA) has approved siponimod (Mayzent, Novartis) to treat adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive (SP) disease, the agency announced.
    "Multiple sclerosis can have a profound impact on a person's life," Billy Dunn, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, said in a statement. "We are committed to continuing to work with companies that are developing additional treatment options for patients with multiple sclerosis."
    Approval was based on results of the phase 3 EXPAND trial, which randomly assigned 1651 patients with SPMS and an Expanded Disability Status Scale score of 3.0 to 6.5 to oral siponimod 2 mg once daily (1105 patients) or placebo (546 patients) for up to 3 years or until the occurrence of a prespecified number of confirmed disability progression events.
    At baseline, the mean time since first multiple sclerosis symptoms was 16.8 years and the mean time since conversion to SPMS was 3.8 years; 64% of patients had not relapsed in the previous 2 years, and 56% needed walking assistance.

    The primary endpoint was time to 3-month confirmed disability progression. This occurred in 26% of the siponimod group and 32% of those receiving placebo (hazard ratio, 0.79; 95% confidence interval [CI], 0.65 - 0.95; relative risk reduction, 21%; P = .013).
    Serious adverse events were reported for 18% of those receiving siponimod vs 15% in the placebo group. Lymphopenia, increased liver transaminase concentration, bradycardia and bradyarrhythmia at treatment initiation, macular edema, hypertension, varicella zoster reactivation, and convulsions occurred more frequently with siponimod than with placebo.
    Initial dose titration mitigated cardiac first-dose effects. Frequencies of infections, malignancies, and fatalities did not differ between groups.
    In addition, secondary outcomes of the trial suggest that reduction in brain volume was less severe in people given the drug compared with those receiving placebo (adjusted mean percentage brain volume change, −0.50% vs −0.65%; between-group difference, 0.15 percentage points [95% CI, 0.07 - 0.23 percentage points]; P = .0002).
    But siponimod was not associated with any significant effect on patients' walking speed in the timed 25-foot walking test.
    Subgroup analyses favored siponimod over placebo across the entire bracket of previous disease duration, disability status, and age, although the treatment effect became less pronounced with increasing age, disability, baseline disease duration, and diminishing signs of disease activity.
    The drug must be dispensed with a patient Medication Guide that describes "important information about the drug's uses and risks," the statement notes. Treatment was shown to increase the risk for infections, so patients should have a complete blood count taken before treatment is initiated. It may cause macular edema, "so patients should contact their physician if they experience a change in vision, the FDA adds.
    It may cause transient bradycardia or decline in lung function. Liver enzymes should be checked before starting the drug, "and health care professionals should closely monitor patients with severe liver impairment," as well as blood pressure during treatment, the statement notes.
    Women of childbearing potential should use effective contraception during and for 10 days after stopping the drug because of potential risk for fetal harm, the agency said. "Health care professionals should monitor patients for posterior reversible encephalopathy syndrome and monitor patients that had treatment with immunosuppressive/immune-modulating therapies because there may be unintended additive immunosuppression with" siponimod.
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    Cite this: FDA Approves Siponimod (Mayzent ) for Multiple Sclerosis - Medscape - Mar 26, 2019.

    Recommendations

    Siponimod Slows Disability in SPMS: EXPAND Published
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    Here are 3 comments on the Medscape page:
    Dr. ALAN diaz10 hours ago
    So essentially we are saying that we have a relatively benign medication QD/PO that can retard progressive disease by at least 16-yrs or total deterioration by 3-yrs ???

    Can Neuro chime in here please! Thanks in advance.


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    Joel Spaulding 7 hours ago
    @Dr. ALAN diaz



    Those were baseline parameters of the participants. The minimal benefit seen in the primary endpoint at 3 months was 26% of participants in study group showed progression vs 32% progression in placebo group.


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    Dr. Gene Zitser 7 hours ago
    Sounds like another Gylenia to me
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    Last edited by Lazarus; 03-27-2019 at 03:48 AM.
    Linda~~~~

    Be the kind of woman that when your feet hit the floor each morning the devil says:"Oh Crap, She's up!"

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    The MSAA has this article about it (March 27):

    https://mymsaa.org/news/mayzent-fda-...ent=email_body

    This part was news to me:

    The FDA’s press release explains that most people with MS start with a relapsing-remitting course of symptom flare-ups and remissions, possibly with some degree of residual disability. Over time, some patients experience an increase in disability that is independent of relapses, and this is referred to as “secondary-progressive MS.” Initially, people with this form of MS may still experience relapses, which is referred to as “active” secondary-progressive MS – the form that Mayzent is approved to treat. Without treatment, many of those with this form of MS eventually experience continued progression of disability without relapses, and this is referred to as “non-active” secondary-progressive MS. Mayzent is not approved for this latter form of the disease.
    I had thought that this drug would be for SPMS. No exceptions. It turns out that there is now "active SPMS" (= still having relapses) and "inactive SPMS" (= not having relapses).

    I wonder why the presence of relapses is so important for all of these drugs. Why aren't they approved for people who don't have relapses--but who do have MS symptoms hitting them every time they try to do anything?

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    Distinguished Community Member Cherie's Avatar
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    Siponimod (Mayzent) is a generic of Gilenya and will be released at $88,000/rear retail price. Novartis also makes Gilenya which currently retails for $91,835, making it the most expensive MS DMT on the market today.

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    Distinguished Community Member Lazarus's Avatar
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    Quote Originally Posted by agate View Post
    This quote is hidden because you are ignoring this member. Show Quote
    The MSAA has this article about it (March 27):

    https://mymsaa.org/news/mayzent-fda-...ent=email_body

    This part was news to me:



    I had thought that this drug would be for SPMS. No exceptions. It turns out that there is now "active SPMS" (= still having relapses) and "inactive SPMS" (= not having relapses).

    I wonder why the presence of relapses is so important for all of these drugs. Why aren't they approved for people who don't have relapses--but who do have MS symptoms hitting them every time they try to do anything?
    Thanks for this information. It is also difficult to interpret what exactly a relapse is when one is SPMS.
    sometimes I am better for a day, two days, part of each day or lots of other combinations of time. Partial relapses? Anyway, I am not seeking any change from rituxan...now. But I always want to have another idea in my back pocket.
    Linda~~~~

    Be the kind of woman that when your feet hit the floor each morning the devil says:"Oh Crap, She's up!"

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    Yes, a “back pocket” next drug. I don’t have one at present.

    ANN
    There comes a time when silence is betrayal.- MLK

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    I am secondary progressive and Ocrevus is not working. I am interested but concerned over possible heart issues.
    Last edited by ssusan; 03-30-2019 at 12:02 PM.

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    Ssusan, have you been on Ocrevus long enough? I don't know when you went on it, but I do remember Cherie saying it took a little while - she might have said as long as 1 1/2 to 2 years for Rituxan to work for her. Of course as we know Rituxan and Ocrevus are much the same drugs.

    I can't remember how long it took for Linda to see a difference after she went on Rituxan.
    Virginia

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