Vumerity vs Mayzent - what's the difference?
Vumerity (diroximel fumarate) and Mayzent (siponimod) are both small molecule drugs used for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
Both drugs are taken orally and were approved for use by the US Food and Drug Administration (FDA) in 2019.
The table below outlines some of their key differences.
The differences between Vumerity and Mayzent
Vumerity (diroximel fumarate) | Mayzent (spionimod) | |
Company | Biogen | Novartis |
Dosage form | Delayed-release capsule | Tablet |
Administration | Cannot be taken with high-fat, high-calories meals or snacks of more than 700 calories and 30 g of fat. | Can be taken with or without food. |
Dosing schedule |
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Testing |
Before treatment is initiated the following is required:
Six months after treatment has started another CBC, including lymphocyte count, is required and then it should be checked again after every 6-12 month as required. The liver function tests should also be repeated as required. |
Before treatment is initiated the following is required:
Patients with certain pre-existing cardiac conditions also require monitoring for six hours after their first dose. |
Mechanism of action | It is not yet known exactly how Vumerity works - what its mechanism of action is - in the treatment of MS, but it is thought to modulate the immune system to reduce inflammation. | Sphingosine 1-phosphate (S1P) receptor modulator. |
Side effects / adverse effects |
The most common adverse events occurring in ≥10% patients treated with Tecfidera (dimethyl fumarate), which has the same active metabolite as Vumerity, are:
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The most common adverse events occurring in ≥10% of patients are:
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Efficacy |
Clinical trial results used for FDA approval were conducted in patients with relapsing-remitting MS (RRMS). RRMS is the most common type of MS and presents as clearly defined attacks of new or increasing neurological symptoms.
Biogen was able to use its clinical trial data for Tecfidera which has the same active metabolite as Vumerity, to gain FDA approval. In clinical trials, treatment with Tecfidera significantly decreased the number of patients who relapsed, the annualized relapse rate, the rate of disability progression and the number of lesions on MRI compared with placebo. |
Clinical trials used for FDA approval were conducted in people with secondary progressive multiple sclerosis (SPMS), which is a type of MS that approximately 1in 4 patients with RRMS will progress to within 10 years.
In a clinical trial, treatment with Mayzent reduced the risk of three-month confirmed disability progression (CDP) by 21% (p = 0.013) compared with placebo. A 52% reduction in the annualized relapse rate was also observed in patients treated with Mayzent, according to the results of a five-year extension of the trial (p<0.0001).The results from the trial extension also showed that the risk of confirmed worsening of cognitive impairment (using Symbol Digit Modalities Test) was reduced by 23% at 6 months in patients who had taken Mayzent during the original trial + the extension trial compared with patients who switched from placebo to Mayzent when the extension trial began (p=0.0014). |
Contraindications |
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Warnings and precautions |
Treatment with Vumerity may need to be interrupted, withheld or discontinued if the following occur:
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Patients taking Mayzent need to be monitored for:
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Interactions |
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Special patient populations |
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Related questions
References
- Food and Drug Administration (FDA). Vumerity. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/211855s002lbl.pdf. [Accessed December 16, 2020].
- Food and Drug Administration (FDA). Mayzent. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/209884s002lbl.pdf. [Accessed December 16, 2020].
- National Multiple Sclerosis Society. FDA Approves Oral Vumerity (Diroximel Fumarate), Similar to Tecfidera, for Relapsing MS. October 30, 2019. Available from: https://www.nationalmssociety.org/About-the-Society/News/FDA-Approves-Oral-Vumerity%E2%84%A2-(Diroximel-Fumarate),#. [Accessed December 16, 2020].
- National Multiple Sclerosis Society. Types of MS. Available from: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. [Accessed December 16, 2020].
- Gold R, Kappos L, Arnold DL, et al. Placebo-controlled phase 3 study of oral BG-12 for relapsing multiple sclerosis [published correction appears in N Engl J Med. 2012 Dec 13;367(24):2362]. N Engl J Med. 2012;367(12):1098-1107. doi:10.1056/NEJMoa1114287.
- Fox RJ, Miller DH, Phillips JT, et al. Placebo-controlled phase 3 study of oral BG-12 or glatiramer in multiple sclerosis [published correction appears in N Engl J Med. 2012 Oct 25;367(17):1673]. N Engl J Med. 2012;367(12):1087-1097. doi:10.1056/NEJMoa1206328.
- Kappos L, Bar-Or A, Cree BAC, et al. Siponimod versus placebo in secondary progressive multiple sclerosis (EXPAND): a double-blind, randomised, phase 3 study [published correction appears in Lancet. 2018 Nov 17;392(10160):2170]. Lancet. 2018;391(10127):1263-1273. doi:10.1016/S0140-6736(18)30475-6.
- GlobeNewswire. Novartis announces new Mayzent® (siponimod) data show sustained effect in delaying disability for up to five years in patients with secondary progressive multiple sclerosis (SPMS). April 21, 2020. Available from: https://www.globenewswire.com/news-release/2020/04/21/2019014/0/en/Novartis-announces-new-Mayzent-siponimod-data-show-sustained-effect-in-delaying-disability-for-up-to-five-years-in-patients-with-secondary-progressive-multiple-sclerosis-SPMS.html. [Accessed December 16, 2020].
Read next
How do Vumerity and Tecfidera compare for multiple sclerosis (MS)?
Vumerity and Tecfidera are administered in the same way and used to treat the same condition, multiple sclerosis (MS). They also have the same active metabolite, which means that they have the same therapeutic effect - work the same way - in people with MS.
However, Vumerity and Tecfidera do have different chemical structures and Vumerity is better tolerated and causes fewer gastrointestinal problems compared with Tecfidera. Continue reading
How long does it take for Vumerity to work?
Vumerity (diroximel fumarate) is a delayed-release capsule used to treat relapsing forms of the autoimmune disorder multiple sclerosis.
Vumerity is thought to have an effect as early as 24 weeks after patients start taking it, based on the results of trials conducted using Tecfidera (dimethyl fumarate), which has the same active metabolite as Vumerity. Continue reading
How does Vumerity work?
It is not yet known exactly how Vumerity works - what its mechanism of action is - in the treatment of MS.
Vumerity's active metabolite, monomethyl fumarate (MMF), is thought to modulate the immune system and have anti-inflammatory and anti-oxidative properties. MMF actives Nrf2 and HCAR2. Continue reading
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