PROVEN EFFECTIVE
in clinical studies

In two separate clinical studies (a one-year and two-year study), ZEPOSIA was proven to be more effective at reducing relapses and lesions (new or enlarging “T2” lesions and T1 Gd-enhancing lesions) than a leading injectable medicine (Avonex).*

The progression of physical disability was measured, too.

*Avonex (interferon beta-1a).

The largest studies of their kind, combined—here are the results

Together, the two studies included more people than any other study to compare one multiple sclerosis (MS) medication to another (not to a placebo). There were 1,769 people in total: ZEPOSIA 880, a leading injectable 889. For detailed information on how the studies were designed click here.

People had fewer relapses with ZEPOSIA

  • ONE-YEAR STUDY

    48% fewer relapses with Zeposia vs a leading injectable medicine in a one-year study

    People taking ZEPOSIA had
    an ARR of 0.181
    vs 0.350
    with a leading injectable.

    Annualized Relapse Rate (ARR) is the average number of relapses a group of people has in one year. A total of 895 people were in this study (ZEPOSIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    38% fewer relapses with Zeposia vs a leading injectable medicine in a two-year study

    People taking ZEPOSIA had
    an ARR of 0.172
    vs 0.276
    with a leading injectable.

    Annualized Relapse Rate (ARR) is the average number of relapses a group of people has in one year. A total of 874 people were in this study (ZEPOSIA 433, a leading injectable 441).


More people were relapse free

  • ONE-YEAR STUDY

    78% of people were relapse free with Zeposia vs 66% of people who took a leading injectable medicine in a one-year study

    VS

    A total of 895 people were in this study (ZEPOSIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    76% of people were relapse free with Zeposia vs 64% of people who took a leading injectable medicine in a two-year study

    VS

    A total of 874 people were in this study (ZEPOSIA 433, a leading injectable 441).

A relapse was defined as new or worsening symptoms directly associated with MS that lasted more than twenty-four hours (after having a mostly stable neurological state for at least thirty days).


Disability progression
was also measured

When taking ZEPOSIA or Avonex 9 out of 10 people experienced no progression of physical disability. There was no significant difference in disability progression between people who took ZEPOSIA (7.6% of people) and those who took a leading injectable medicine (7.8% of people).

There was no significant difference
in disability progression between people who took ZEPOSIA (7.6% of people) and those who took a leading injectable medicine (7.8% of people).
Physical disability progression was measured every 3 months and combined
from both studies.


Fewer new or enlarging lesions (T2) in both studies

  • ONE-YEAR STUDY

    48% fewer new or enlarging lesions (T2) with Zeposia vs a leading injectable medicine in a one-year study

    People taking ZEPOSIA had an average of 1.47 lesions (T2) vs 2.84 with a leading injectable.

    A total of 895 people were in this study (ZEPOSIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    42% fewer new or enlarging lesions (T2) with Zeposia vs a leading injectable medicine in a two-year study

    People taking ZEPOSIA had an average of 1.84 lesions (T2) vs 3.18 with a leading injectable.

    A total of 874 people were in this study (ZEPOSIA 433, a leading injectable 441).

T2 (lesions) refers to a type of magnetic resonance imaging (MRI) scan (a T2-weighted image) that can be used to identify the total number of lesions a person has.

Fewer lesions showing active inflammation (T1 Gd-enhancing)

T1 Gadolinium (Gd)-enhancing lesions are areas of active inflammation that show current MS activity in the brain.

  • ONE-YEAR STUDY

    63% fewer T1 Gd-enhancing lesions with Zeposia than a leading injectable medicine (in a one-year study)

    People taking ZEPOSIA had an average of 0.16 lesions (T1 Gd-enhancing) vs 0.43 with a leading injectable.

    A total of 895 people were in this study (ZEPOSIA 447, a leading injectable 448).

  • TWO-YEAR STUDY

    53% fewer T1 Gd-enhancing lesions with Zeposia than a leading injectable medicine in a two-year study

    People taking ZEPOSIA had an average of 0.18 lesions (T1 Gd-enhancing) vs 0.37 with a leading injectable.

    A total of 874 people were in this study (ZEPOSIA 433, a leading injectable 441).

Learn about ZEPOSIA safety & side effects >

Once-daily oral dosing has held great
appeal to my patients, and I am pleased
with the clinical results seen with ZEPOSIA."

— Edward J. Fox, MD, PhD
Director, Multiple Sclerosis Clinic of Central Texas

How the clinical studies were designed

Each of the two clinical studies for ZEPOSIA was randomized and double-blind. That means participants were chosen randomly to receive either ZEPOSIA or a leading injectable medicine, and neither the professionals giving the medication nor the people taking it were told which medication was being administered.

More details about the studies

Prior to joining the studies, all participants had experienced at least one relapse within the past two years and had evidence of T1 Gd-enhancing lesions.

The average age across both studies was

35½ years old

and around

65% were female

Other areas to explore:

  • Learn about
    ZEPOSIA safety

    The safety of ZEPOSIA was evaluated in two separate clinical studies. Learn about the side effects that were reported.

    Side effects

  • A co-pay offer to help save§

    Eligible patients can receive a co-pay savings offer to help with the monthly cost of treatment.

    Sign up now

    §Program terms and eligibility criteria apply.

Paid consultant of Bristol Myers Squibb.

Important Safety Information

Do not take ZEPOSIA if you:

  • have had a heart attack, chest pain (unstable angina), stroke or mini-stroke (transient ischemic attack or TIA), or certain types of heart failure in the last 6 months
  • have or have had a history of certain types of an irregular or abnormal heartbeat (arrhythmia) that is not corrected by a pacemaker
  • have untreated, severe breathing problems during your sleep (sleep apnea)
  • take certain medicines called monoamine oxidase (MAO) inhibitors

Talk to your healthcare provider before taking ZEPOSIA if you have any of these conditions or do not know if you have any of these conditions.

ZEPOSIA may cause serious side effects, including:

  • Infections. ZEPOSIA can increase your risk of serious infections that can be life-threatening and cause death. ZEPOSIA lowers the number of white blood cells (lymphocytes) in your blood. This will usually go back to normal within 3 months of stopping treatment. Your healthcare provider may do a blood test of your white blood cells before you start taking ZEPOSIA.

    Call your healthcare provider right away if you have any of these symptoms of an infection during treatment with ZEPOSIA and for 3 months after your last dose of ZEPOSIA:

    • fever
    • feeling very tired
    • flu-like symptoms
    • cough
    • painful and frequent urination (signs of a urinary tract infection)
    • rash
    • headache with fever, neck stiffness, sensitivity to light, nausea, or confusion (symptoms of meningitis, an infection of the lining around your brain and spine)

    Your healthcare provider may delay starting or may stop your ZEPOSIA treatment if you have an infection.

  • Slow heart rate (also known as bradyarrhythmia) when you start taking ZEPOSIA. ZEPOSIA may cause your heart rate to temporarily slow down, especially during the first 8 days. You will have a test to check the electrical activity of your heart called an electrocardiogram (ECG) before you take your first dose of ZEPOSIA.

    Call your healthcare provider if you experience the following symptoms of slow heart rate:

    • dizziness
    • lightheadedness
    • feeling like your heart is beating slowly or skipping beats
    • shortness of breath
    • confusion
    • chest pain
    • tiredness

    Follow directions from your healthcare provider when starting ZEPOSIA and when you miss a dose.

Continue reading for additional possible serious side effects of ZEPOSIA.

Before taking ZEPOSIA, tell your healthcare provider about all of your medical conditions, including if you:

  • have a fever or infection, or are unable to fight infections due to a disease, or take or have taken medicines that lower your immune system
  • before you start ZEPOSIA, your healthcare provider may give you a chickenpox (varicella zoster virus) vaccine if you have not had one before
  • have had chickenpox or have received the vaccine for chickenpox. Your healthcare provider may do a blood test for the chickenpox virus. You may need to get the full course of the vaccine and wait 1 month before taking ZEPOSIA
  • have a slow heart rate
  • have an irregular or abnormal heartbeat (arrhythmia)
  • have a history of stroke
  • have or have had heart problems, including a heart attack or chest pain
  • have high blood pressure
  • have liver problems
  • have breathing problems, including during your sleep
  • have eye problems, especially an inflammation of the eye called uveitis
  • have diabetes
  • are or plan to become pregnant or if you become pregnant within 3 months after you stop taking ZEPOSIA. ZEPOSIA may harm your unborn baby. If you are a female who can become pregnant, talk to your healthcare provider about what birth control method is right for you during your treatment with ZEPOSIA and for 3 months after you stop taking ZEPOSIA
  • are breastfeeding or plan to breastfeed. It is not known if ZEPOSIA passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take ZEPOSIA

Tell your healthcare provider about all the medicines you take or have recently taken, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Using ZEPOSIA with other medicines can cause serious side effects. Especially tell your healthcare provider if you take or have taken:

  • medicines that affect your immune system, such as alemtuzumab
  • medicines to control your heart rhythm (antiarrhythmics) or heartbeat
  • strong CYP2C8 inhibitors such as gemfibrozil or clopidogrel
  • medicines that inhibit breast cancer resistance protein transporters, such as cyclosporine and eltrombopag
  • CYP2C8 inducers such as rifampin
  • opioids (pain medicine), medicines to treat depression, and medicines to treat Parkinson’s disease

You should not receive live vaccines during treatment with ZEPOSIA, for at least 1 month before taking ZEPOSIA and for 3 months after you stop taking ZEPOSIA. Vaccines may not work as well when given during treatment with ZEPOSIA.

ZEPOSIA can cause serious side effects, including:

  • liver problems. Your healthcare provider will do blood tests to check your liver before you start taking ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:
    • unexplained nausea
    • vomiting
    • stomach area (abdominal) pain
    • tiredness
    • loss of appetite
    • yellowing of the whites of your eyes or skin
    • dark-colored urine
  • increased blood pressure. Your healthcare provider should check your blood pressure during treatment with ZEPOSIA. A sudden, severe increase in blood pressure (hypertensive crisis) can happen when you eat certain foods that contain high levels of tyramine
  • breathing problems. Some people who take ZEPOSIA have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems
  • a problem with your vision called macular edema. Your risk of macular edema is higher if you have diabetes or have had an inflammation of your eye called uveitis. Your healthcare provider should test your vision before you start taking ZEPOSIA if you are at higher risk for macular edema or any time you notice vision changes during treatment with ZEPOSIA. Call your healthcare provider right away if you have any of the following symptoms:
    • blurriness or shadows in the center of your vision
    • sensitivity to light
    • a blind spot in the center of your vision
    • unusually colored vision
  • swelling and narrowing of the blood vessels in your brain. Posterior Reversible Encephalopathy Syndrome (PRES) is a rare condition that has happened with ZEPOSIA and with drugs in the same class. Symptoms of PRES usually get better when you stop taking ZEPOSIA. If left untreated, it may lead to stroke. Your healthcare provider will do a test if you have any symptoms of PRES. Call your healthcare provider right away if you have any of the following symptoms:
    • sudden severe headache
    • sudden confusion
    • sudden loss of vision or other changes in your vision
    • seizure
  • severe worsening of MS after stopping ZEPOSIA. When ZEPOSIA is stopped, symptoms of MS may return and become worse compared to before or during treatment. Always talk to your healthcare provider before you stop taking ZEPOSIA for any reason. Tell your healthcare provider if you have worsening symptoms of MS after stopping ZEPOSIA.
  • allergic reactions. Call your healthcare provider if you have symptoms of an allergic reaction, including a rash, itchy hives, or swelling of the lips, tongue, or face

The most common side effects of ZEPOSIA can include:

  • upper respiratory tract infections
  • elevated liver enzymes
  • low blood pressure when you stand up (orthostatic hypotension)
  • painful and frequent urination (signs of urinary tract infection)
  • back pain
  • high blood pressure

These are not all of the possible side effects of ZEPOSIA. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

INDICATION

ZEPOSIA® (ozanimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
It is not known if ZEPOSIA is safe and effective in children.

Please see full Prescribing Information, including Medication Guide.

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