FDA Approves Zeposia (ozanimod), But Delayed Due to COVID-19 Pandemic

The United States Food and Drug Administration (US FDA) has approved Zeposia for the treatment of relapsing forms of MS (RMS). These include:

  • Clinically isolated syndrome
  • Relapsing-remitting disease
  • Active secondary progressive disease

How is ozanimod different from other MS treatments?

Zeposia (ozanimod) is approved for use in adults only and comes as an oral capsule. Zeposia is different from other similar MS drugs on the market in that it does not require genetic testing or a first-dose observation period. People taking a drug that has a first-dose observation period are typically required to be monitored by their doctor for several hours after they start the drug. Their heart rate and other vital signs will be monitored during this time, and additional tests may be run. Zeposia is unique in that it does not require these additional steps to begin treatment.

Delaying Zeposia due to the COVID-19 pandemic

Although Zeposia has been approved by the FDA, it will not be put on the market right away. This is due to the COVID-19 pandemic and the unknown effects it has been having on our society. The maker of Zeposia, Bristol Myers Squibb, announced that they will work with the neurology community and monitor conditions to determine when the best time will be to release the drug.

How does Zeposia work?

Zeposia belongs to a class of drugs called sphingosine 1-phosphate (S1P) receptor modulators. It is not known exactly how Zeposia works in MS. However, it is thought to play a role in preventing certain white blood cells from leaving lymph nodes and entering the central nervous system. This may help prevent MS-related inflammation and damage in the brain and spinal cord.

Zeposia in clinical trials

Zeposia received approval based on the results of 2 clinical trials. These trials were called the SUNBEAM and RADIANCE trials. Together, they involved over 2,600 people with RMS. In each trial, Zeposia was compared to an already available treatment for RMS called Avonex (interferon beta-1a).

The annualized relapse rate (ARR) was compared in the trials. This is a measure of relapses over time. Overall, Zeposia decreased the ARR compared to Avonex by 48 percent at the 1-year mark, and 38 percent at the 2-year mark. Further, Zeposia decreased the number of MS-related lesions in the brain compared to Avonex. Zeposia also reduced the number of new or enlarging lesions as well. These results were found at both the 1- and 2-year marks, and show that Zeposia may have benefit over other currently available drugs in treating RMS.

What are the side effects of Zeposia?

The most common side effects of Zeposia include:

  • Upper respiratory infection
  • Urinary tract infection
  • Liver function changes
  • High blood pressure or changes in blood pressure when standing up (orthostatic hypotension)
  • Back pain

Things to know about Zeposia

Zeposia can impact many different systems within the body, including the heart, liver, lungs, immune system, and eyes. Although many of these effects are rare, they can still be serious. Your doctor may need to run certain tests before you start Zeposia, so they can track any changes over time. They may also recommend that you receive specific vaccines before starting the drug, as some vaccines cannot be given while taking Zeposia. This is to help best protect you from infection.

Before starting Zeposia, tell your doctor if you:

  • Have a history of heart-related problems such as heart attack, regular chest pain, heart failure, heart rhythm changes, or stroke
  • Have untreated sleep apnea
  • Have recently had an infection or have taken a medication that may impact your immune system
  • Have a history of liver problems
  • Have a history of lung issues
  • Have a history of eye conditions (including uveitis) or have another condition that could increase your risk of developing eye problems (like diabetes)
  • Are pregnant or planning to become pregnant
  • Have a partner who could become pregnant while you’re taking Zeposia
  • Are breastfeeding or planning to breastfeed
  • Are taking any other medications, vitamins, or supplements
  • Have any vaccines scheduled for the near future

Read the prescribing information to learn more about Zeposia.1,2

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