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FDA Approves Oral Zeposia® (Ozanimod) for Relapsing Forms of MS – Marketing Delayed

March 26, 2020

  • The U.S. Food and Drug Administration has approved Zeposia® (ozanimod, Bristol Myers Squibb) as an oral disease-modifying therapy for adults with relapsing forms of MS.
  • The company will delay marketing this therapy while the U.S. healthcare system is dealing with the COVID-19 pandemic.  At this time a timetable for when Zeposia will be available has not been announced.
  • Relapsing forms of MS includes people with 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.
  • 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. We hope that the marketing delay will be of short duration.”

Additional information on availability, cost, and any patient support programs will be provided when they become available.
 
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 and people with severe, untreated sleep apnea.
 
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.
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
 
 
 

About Multiple Sclerosis

Multiple sclerosis is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body. Symptoms range from numbness and tingling to blindness and paralysis. The progress, severity and specific symptoms of MS in any one person cannot yet be predicted, but advances in research and treatment are leading to better understanding and moving us closer to a world free of MS. Most people with MS are diagnosed between the ages of 20 and 50, with at least two to three times more women than men being diagnosed with the disease. MS affects more than 2.3 million people worldwide.

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