It’s time to talk about one of the things that matters most about an MS treatment: how well it works.
MAVENCLAD was studied in a 96-week clinical trial with relapsing MS patients to measure how well it works (efficacy) and to evaluate its safety.
The clinical trial compared MAVENCLAD to placebo in 3 key ways:
Here’s how MAVENCLAD performed when compared to placebo in a 96-week clinical study.
DECREASED THE NUMBER OF LESIONS
Two types of MRI scans are typically used for people with MS. T1-weighted gadolinium-enhanced (T1-Gd+) scans show bright areas that indicate areas of active inflammation. An active T2-weighted (T2) MRI scan shows the total number of both new and enlarging lesions.
The clinical trial results presented the median and mean numbers of lesions patients had throughout the trial. The median is the number in the middle—it has the same number of data points above and below. For example, in the list 1, 2, 3, 4, 5, 6, 7, number 4 is the median. The mean is the average number of lesions experienced.
Both types of analyses showed that MAVENCLAD reduced the number of MRI lesions as compared to placebo.
DECREASED DISABILITY PROGRESSION
MAVENCLAD significantly reduced the risk of 3-month confirmed EDSS (Expanded Disability Status Scale) progression vs placebo:
WHAT IS THE EDSS?
Disability progression is a common measure of MS treatments in clinical trials. It can be charted on the EDSS.
About 24% of cladribine-treated patients in the clinical trial program were followed for up to 8 years. The mean time of the study follow-up was about 4.8 years. This helped to provide a clearer picture of the long-term safety of MAVENCLAD. These clinical trials evaluated the risk of side effects from MAVENCLAD. Keep in mind that the types and seriousness of side effects vary from patient to patient.
It is not known if MAVENCLAD is safe and effective for people to restart MAVENCLAD treatment 2 years after completing their 2 yearly treatment courses.
The person in the photo below is not an actual MAVENCLAD patient.
Find out how to take MAVENCLAD.
*Not taken every day of the year.
SEE HOWMAVENCLAD may cause serious side effects, including:
Do not take MAVENCLAD if you:
Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:
How should I take MAVENCLAD?
Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.
MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:
The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.
These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.
MAVENCLAD is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include relapsing-remitting disease and active secondary progressive disease, in adults. Because of its safety profile, MAVENCLAD is generally used in people who have tried another MS medicine that they could not tolerate or that has not worked well enough.
MAVENCLAD is not recommended for use in people with clinically isolated syndrome (CIS).
It is not known if MAVENCLAD is safe and effective in children under 18 years of age.
MAVENCLAD may cause serious side effects, including:
Do not take MAVENCLAD if you:
Before you take MAVENCLAD, tell your healthcare provider about all of your medical conditions, including if you:
How should I take MAVENCLAD?
Your healthcare provider will continue to monitor your health during the 2 yearly treatment courses, and for at least another 2 years during which you do not need to take MAVENCLAD. It is not known if MAVENCLAD is safe and effective in people who restart MAVENCLAD treatment more than 2 years after completing 2 yearly treatment courses.
MAVENCLAD can cause serious side effects. If you have any of these symptoms listed below, call your healthcare provider right away:
The most common side effects of MAVENCLAD include: upper respiratory infection, headache, and low white blood cell counts.
These are not all the possible side effects of MAVENCLAD. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please see full Prescribing Information/Medication Guide, including serious side effects, for additional Important Safety Information.