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Vumerity vs Mayzent - what's the difference?

Medically reviewed by N. France, BPharm. Last updated on Dec 16, 2020.

Official Answer

by Drugs.com

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
  • Taken twice a day
  • A half-dose is taken for the first seven days
  • Taken once a day
  • A five-day titration schedule is followed when treatment is initiated
  • Some patients may only need to take half the usual maintenance dose. A blood test is used to identify such patients
Testing Before treatment is initiated the following is required:
  • A complete blood cell count (CBC), including lymphocyte count.
  • Serum aminotransferase, alkaline phosphatase and total bilirubin levels should also be checked

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:
  • CYP2C9 genotyping
  • CBC
  • Ophthalmic evaluation
  • Cardiac evaluation, including an electrocardiogram (ECG)
  • Check prior and current medication use to identify any with immunosuppressive effects to avoid a possible additive immunosuppressive effect
  • Test for antibodies to varicella zoster virus and vaccinate if antibody negative
  • Liver function tests for transaminase and bilirubin are also necessary

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:
  • Flushing
  • Abdominal pain
  • Diarrhea
  • Nausea
Clinical trial data for Tecfidera were used to gain approval of Vumerity.
The most common adverse events occurring in ≥10% of patients are:
  • Headache
  • Hypertension
  • Transaminase increases
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
  • Should not be taken by people taking Tecfidera, which has the same active metabolite
  • Not suitable for people with a CYP2C9*3/*3 genotype
  • Should not be used in patients that have had a myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or class III/IV heart failure in the last six months
  • Should not be used in patients with Mobitz type II second-degree, third-degree AV block, or sick sinus syndrome, unless they have a functioning pacemaker
Warnings and precautions Treatment with Vumerity may need to be interrupted, withheld or discontinued if the following occur:
  • Herpes zoster and other serious opportunistic infections
  • Liver injury
  • Anaphylaxis and angioedema
  • Progressive multifocal leukoencephalopathy
  • Lymphopenia
  • Fetal risk
Patients taking Mayzent need to be monitored for:
  • Infections
  • Liver injury
  • Macular edema
  • Bradyarrhythmia and atrioventricular conduction delays
  • Respiratory effects - decline in pulmonary function
  • Increased blood pressure
  • Fetal risk
Interactions
  • Do not take Vumerity with Tecfidera, which has the same active metabolite
  • Avoid live attenuated vaccines during use and for up to four weeks after stopping treatment
  • Avoid using with moderate CYP2C9 inhibitors and moderate or strong CYP3A4 inhibitors
  • Avoid using with moderate CYP2C9 and strong CYP3A4 inhibitors
Special patient populations
  • Not recommended in patients with moderate or severe renal impairment
  • May cause fetal harm
  • Mayzent is not suitable for people with a CYP2C9*3/*3 genotype
  • May cause fetal harm
References

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