MS News that Caught My Eye Last Week: Reaction to SPMS DMT Approval, Ozanimod’s FDA Application, Caregiving Partnerships, a New Preventive Medication?

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by Ed Tobias |

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MS Patient Groups React Favorably to Mayzent Approval, But Question Therapy’s Price Tag

The approval of this medication is very good news. However, as the headline indicates, it comes with a relatively hefty cost. It’s approved for active secondary progressive multiple sclerosis (SPMS), and many of us have SPMS that’s not considered to be active. I’m one of them. What about us?

National organizations that represent patients with multiple sclerosis (MS) welcome the U.S. Food and Drug Administration’s March 26 approval of Novartis’ oral therapy Mayzent (siponimod) — but they complain that, at $88,500 per year, the treatment is overpriced.

The Multiple Sclerosis Association of America (MSAA) clearly is upbeat about the new medication. The organization’s chief medical consultant, Jack Burks, MD, noted that Mayzent is the only disease-modifying therapy to be approved in recent years for active secondary progressive MS, or SPMS. It also treats clinically isolated syndrome (CIS) and relapsing-remitting MS (RRMS).

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Celgene Seeking FDA Approval for Ozanimod to Treat Adults with Relapsing MS

Here’s another new medication in the pipeline that leaves me scratching my head. It’s aimed at people with RRMS. In the United States, there are more than a dozen DMTs already available to attack RRMS. But there’s only one DMT available for SPMS and one for primary progressive MS. Am I wrong to think that the development of new MS medications should be refocused to help those with progressive forms of the disease?

An application has been submitted to approve ozanimod as an oral treatment for adults with relapsing forms of multiple sclerosis (MS) in the U.S., according to its developer, Celgene.

“New oral treatment options with differentiated profiles like ozanimod are needed to help address an unmet need for people with relapsing forms of MS,” said Jay Backstrom, MD, Celgene’s chief medical officer in a press release.

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Caregivers of MS Patients Should Not Neglect Own Needs, Expert Says in MSAA Webinar

I’ll bet that being a caregiver is harder than being a patient. But, according to nurse practitioner Megan Weigel, it can be made easier if the two work together as a caregiving team.

People who take care of their own needs while caring for a loved one with multiple sclerosis (MS) are more likely to be successful, and enjoy a mutually rewarding relationship. And the best way to ensure that partners’ needs are met is for them to communicate openly and often.

These were among the main points made by MS specialist and nurse practitioner Megan Weigel of Jacksonville, Florida, during a March 18 webinar titled “The Partnership of Care: Redefining Caregiver to Care Partner.”

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T20K in Good Position to Become Preventive MS Treatment, Cyxone Says

Could this medication, made from plants, actually prevent MS? The company that’s making it thinks so. But our news story uses phrases such as “seems able to prevent or slow disease progression,” “might become,” and “will be in a good position to become a new prophylactic treatment.” And so far the treatment has only been tried on mice. An application for a Phase 1 patient trial is planned for the second quarter of this year. So, read this with interest, and be glad that something like this is in the works, but don’t expect to see it available for patients anytime soon, if ever.

T20K, Cyxone’s lead compound for treating multiple sclerosis (MS), seems able to prevent or slow disease progression, according to data from preclinical studies. Based on these findings, the company is confident that T20K might become a prophylactic (preventive) medication for MS in the near future.

T20K is a unique compound derived from a plant protein. Researchers from the Medical University of Vienna (Austria) and the University Medical Center in Freiburg (Germany) were the first to show that T20K was able to block the activity of pro-inflammatory cytokines (molecules that mediate immune and inflammatory responses), such as interleukin-2 (IL-2), and reduce symptoms of MS in animal models of the disease without toxic side effects.

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Note: Multiple Sclerosis News Today is strictly a news and information website about the disease. It does not provide medical advice, diagnosis, or treatment. This content is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition. Never disregard professional medical advice or delay in seeking it because of something you have read on this website. The opinions expressed in this column are not those of Multiple Sclerosis News Today or its parent company, BioNews Services, and are intended to spark discussion about issues pertaining to multiple sclerosis.


DJ Hartt avatar

DJ Hartt

Why is the release of siponimod hailed as a breakthrough when clearly it is not? It does not touch non-active SPMS patients, which the majority of SPMS are or will be.

Its results show a pathetic 21% reduction in progression at a whopping 3 months and 26% at 6 months in only "active" SPMS, a small subgroup of SPMS.

At least FDA reads through the nonsense of this grossly ineffective overpriced ripoff of fingolimod (incidentally also owned by Novartis who stopped their progressive trials on fingolimod second to it coming off patent) that treats a very small subgroup of "active" SPMS.

"However, according to an FDA press announcement, “in the subgroup of patients with non-active SPMS, the results were not statistically significant.” People with non-active SPMS experience disability progression but without relapses."

How is progressive MS research to evolve into a meaningful treatment with approval of recycled ineffective immunosuppressant treatments like siponimod (only approved for "active" SPMS) and ocrezulimab (only approved for "active" PPMS)?

It is clear that these immunosuppressant neuroinflammatory medications do not work in progressive MS no matter how Pharma tries to statistically manipulate the numbers.

History will not be kind to Pharma/NMSS/neurology selling false hopes for profit to a very vulnerable MS population.

Paula mieczkowski avatar

Paula mieczkowski

T20K sounds so wonderful. My only thought about it is what’s wrong with America? Austria, Germany? Really... are we not training enough young folks smart enough to find these types of compounds or plants? Where are America’s fine scientists? Biologists etc. that it takes to be there first?


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