Originally released March 26, 2020; Updated with new information and FAQs
- The U.S. Food and Drug Administration approved Zeposia® (ozanimod, Bristol Myers Squibb) in March 2020 as an oral disease-modifying therapy for adults with relapsing forms of MS.
- As of June 1, 2020, Zeposia is now available for prescription.
- Relapsing forms of MS includes clinically isolated syndrome (an initial episode of neurological symptoms), relapsing-remitting MS, and active secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses and/or new MRI activity.
- Zeposia is similar to Gilenya® (fingolimod, Novartis International AG) and Mayzent® (siponimod, Novartis International AG). Zeposia is thought to act by retaining certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the central nervous system.
- In two phase 3 clinical trials, Zeposia significantly reduced annual relapse rates compared with Avonex® (interferon beta-1a, Biogen), and also reduced new MRI-detected disease activity. There was no significant difference in the proportion of people who experienced disease progression between those taking Zeposia or Avonex.
- The most common adverse reactions reported from clinical trials were upper respiratory infection, increases in liver function tests, low blood pressure after standing up (orthostatic hypotension), urinary tract infection, back pain, and high blood pressure. Zeposia may cause infections, including serious infections.
- Starting Zeposia may result in temporary reductions in heart rate. To help reduce this potential side effect, Zeposia is taken in gradually larger doses over 7 days before the standard maintenance dose is achieved. There is no requirement for in-office observation when an individual receives the first dose.
- When this therapy is launched, it will provide another treatment option for people living with relapsing forms of MS.
“MS affects each person in a unique way, and response to disease-modifying therapies may vary,” said Kathy Costello, MS, ANP-BC, MSCN, Associate Vice President of Healthcare Access at the National MS Society. Having access to multiple treatment options is important, so the approval of oral Zeposia is a welcome addition for people with relapsing forms of MS.
Download the Medication Guide for patients (.pdf)
Download prescribing information (.pdf)
ADDITIONAL DETAILS
About Zeposia: Zeposia (zeh-poe’-see-ah) is a selective sphingosine 1-phosphate receptor modulator. It is thought to act by promoting the retention of certain white blood cells in the body’s lymph nodes, keeping them out of circulation and from entering the brain and spinal cord. Similar therapies are approved by the FDA to treat MS: Gilenya
® (fingolimod, Novartis International AG) and Mayzent
® (siponimod, Novartis International AG). Results from two phase 3 clinical trials were published in Lancet Neurology 2019 (
SUNBEAM trial and
RADIANCE trial).
Potential Benefits: Two phase 3 clinical trials, involving more than 2,600 people with relapsing MS, compared two different doses of daily oral Zeposia to Avonex (injected into the muscle once weekly). Zeposia was found to significantly reduce annual relapse rates, and reduced new MRI-detected signs of disease activity. Zeposia was not shown to slow disability progression significantly more than Avonex.
Potential Risks: The most common adverse reactions reported from clinical trials were upper respiratory infection, increases in liver function tests, low blood pressure after standing up (orthostatic hypotension), urinary tract infection, back pain, and high blood pressure. The serious adverse events reported to be more likely for those taking Zeposia included infections. History of current or prior immune-suppressing medications may cause Zeposia to further reduce the ability to fight infections. Zeposia is not recommended for people with certain types of heart conditions.
Prescribing information includes several warnings and precautions, including the following.
Zeposia:
- reduces white blood counts, and so may increase the risk of infections, including serious infections
- may cause macular edema (swelling in the back of the eye)
- may cause transient decreases in heart rate
- may reduce lung function
- may cause liver injury
- may increase blood pressure
- may cause harm to a fetus, so women of childbearing potential should use contraception during and for 3 months after stopping Zeposia.
- may cause severe disability after stopping Zeposia
The Zeposia
Medication Guide provides advice about symptoms to be alert to and about which individuals taking Zeposia should inform their healthcare providers.
Pre-dosing Tests and Evaluations:
The prescribing information contains advice to health care providers about tests people should undergo before beginning to take Zeposia. These include:
- Complete blood count
- Liver function tests
- Eye examination in those with a history of certain eye disorders (uveitis or macular edema) or diabetes mellitus
- Electrocardiogram/cardiac evaluation
- Blood test for antibodies to varicella zoster virus (Shingles virus). In those who are negative, VZV vaccination is recommended. If live attenuated vaccine immunizations are required, they should be administered at least 1 month prior to initiation of Zeposia.
The company has established a
website where additional information about Zeposia and its Zeposia 360 Support™ program is available. Individuals with MS and healthcare providers may also call for more information at 1-833-ZEPOSIA (1-833-937-6742).
Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider, taking into account a variety of factors, including the effectiveness of any therapy they are currently taking, and weighing potential risks and benefits, costs and lifestyle factors.
Read more about medications for MS
Avonex is a registered trademark of Biogen
Gilenya is a registered trademark of Novartis
Mayzent is a registered trademark of Novartis
Zeposia is a registered trademark of Celgene Corporation
Zeposia 360 Support is a trademark of Bristol Myers Squibb
FAQ About the FDA Approval and Launch of Oral Ozanimod
– Brand Name Zeposia – for Relapsing MS
Q. What types of MS is Zeposia approved to treat?
A. The FDA has approved Zeposia for the treatment of relapsing forms of MS including
clinically isolated syndrome (an initial episode of neurological symptoms),
relapsing-remitting MS, and active
secondary progressive MS. People with active secondary progressive MS have had progression of disability but still experience acute relapses or new MRI activity.
Q. How is Zeposia taken?
A. Zeposia is a capsule taken by mouth once daily. Starting Zeposia may result in temporary reductions in heart rate. To help reduce this potential side effect, Zeposia is taken in gradually larger doses over 7 days before the standard maintenance dose is achieved. There is no requirement for in-office observation when an individual receives the first dose.
Q. What are the potential side effects of Zeposia?
A. The most common adverse reactions reported from clinical trials were upper respiratory infection, increases in liver function tests, low blood pressure after standing up (orthostatic hypotension), urinary tract infection, back pain, and high blood pressure. The serious adverse events reported to be more likely for those taking Zeposia included infections. History of current or prior immune-suppressing medications may cause Zeposia to further reduce the ability to fight infections. Zeposia is not recommended for people with certain types of heart conditions.
Prescribing information includes several warnings and precautions, including the following.
Zeposia:
- reduces white blood counts, and so may increase the risk of infections, including serious infections
- may cause macular edema (swelling in the back of the eye)
- may cause transient decreases in heart rate
- may reduce lung function
- may cause liver injury
- may increase blood pressure
- may cause harm to a fetus, so women of childbearing potential should use contraception during and for 3 months after stopping Zeposia.
- may cause severe disability after stopping Zeposia
The Zeposia
Medication Guide provides advice about symptoms to be alert to and about which individuals taking Zeposia should inform their healthcare providers.
Q. Why should a person with MS consider taking a disease-modifying therapy?
A. Taking a disease-modifying therapy is currently the best way to reduce MS disease activity and future deterioration. Studies comparing people in clinical trials who started therapy earlier than those on inactive placebo suggest that early treatment offered important benefits against the accumulation of disability, which were generally not experienced to the same degree by those who started treatment later.
Selecting an MS therapy should be done by people with MS in collaboration with their MS healthcare provider, taking into account a variety of factors, including the effectiveness of any therapy they are currently using, and weighing potential risks and benefits, costs and lifestyle factors.
Q. When will Zeposia become available?
A. As of June 1, 2020, Bristol Myers Squibb has announced that Zeposia is ready to be prescribed.
Should I switch from my current therapy to Zeposia?
A. The decision about whether to take Zeposia should be made in collaboration with your MS provider taking into account a variety of factors including the effectiveness of any therapy you are currently using, the potential risks and benefits, as well as costs and lifestyle factors. Important questions to be considered and discussed with your provider in terms of Zeposia include:
- How am I doing on my current therapy?
- What is my tolerance for the risk of known side effects?
- What is my tolerance for the risk of adverse consequences that might emerge with longer-term use?
- How will my medication choice affect my ability or plans to become pregnant?
- What are the comparative costs of my current therapy versus Zeposia?
Q. How long would a person take Zeposia?
A. There is no specified time limit for taking Zeposia.
Q. Are there any risk factors or medical conditions that would make it inappropriate for an individual to take Zeposia?
A. Zeposia should not be prescribed for people with certain types of heart conditions, for people with severe untreated sleep apnea, or for people who take a monoamine oxidase inhibitor (which is an early form of antidepressant, such as selegiline, phenelzine, and linezolid).
In addition, it is not recommended that a person take certain other medications along with Zeposia, since this may cause high blood pressure. These include opioid pain killers, medicines to treat depression, certain medicines to treat MS-related pain, medicines to treat Parkinson’s disease, and certain over-the-counter decongestants (pseudoephedrine). Blood pressure should be monitored for individuals taking these types of medications along with Zeposia.
Q. Will a person taking Zeposia have to get any special medical tests or monitoring?
A. The prescribing information contains advice to health care providers about tests people should undergo before beginning to take Zeposia. These include:
- Complete blood count
- Liver function tests
- Eye examination in those with a history of certain eye disorders (uveitis or macular edema) or diabetes mellitus
- Electrocardiogram/cardiac evaluation
- Blood test for antibodies to varicella zoster virus (Shingles virus). In those who are negative, VZV vaccination is recommended. If live attenuated vaccine immunizations are required, they should be administered at least 1 month prior to initiation of Zeposia.
There is no recommendation for any ongoing lab testing after a person begins taking Zeposia.
Q. What will Zeposia cost?
A. The list price of Zeposia has been announced as $86,000 per year. The actual cost to an individual who has MS will depend on the provisions of his or her insurance coverage and the degree to which that individual will be eligible for programs designed to assist with out-of-pocket costs.
Q. Will my health insurance cover Zeposia?
A. Coverage will depend on individual insurance plans.
Q. Is there a generic form of Zeposia?
A. No.
Q. Where can I get information about the patient support that Bristol Myers Squibb plans to provide?
A. Individuals with MS and health care providers may call for information at 1-833-ZEPOSIA (1-833-937-6742). In addition, the company has launched a
website for information.
Q. Is Zeposia being tested in primary progressive MS or non-active secondary-progressive MS?
A. Not at this time.
Q. Is it safe to start on Zeposia during the COVID-19 pandemic?
A. Many experts believe it is safe to start a disease-modifying therapy (DMT), including Zeposia, during the COVID-19 pandemic. Zeposia may increase your risk of infections, including COVID-19. This must be weighed against other factors including your MS activity, your age, other medical conditions and other potential factors that could impact your DMT. This is a difficult decision and needs a thorough discussion with your MS provider. The company is making it possible for many individuals to get at-home medical testing required before an individual begins taking Zeposia. Consult their
website for more information.