Vumerity vs Mayzent - what's the difference?
Medically reviewed by N. France, BPharm. Last updated on Dec 16, 2020.
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)|
|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.|
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:
The most common adverse events occurring in ≥10% of patients are:
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).
|Warnings and precautions||
Treatment with Vumerity may need to be interrupted, withheld or discontinued if the following occur:
Patients taking Mayzent need to be monitored for:
|Special patient populations||
- 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].
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