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FDA Sends Letter Stating that the Application to Market Oral Ozanimod for MS is Not Ready for Review

February 28, 2018

  • The U.S. Food and Drug Administration has issued a “Refusal to File” letter to Celgene Corporation indicating that the company’s application to market oral ozanimod to treat relapsing forms of multiple sclerosis is not ready for review in its current form.
  • Ozanimod is similar to the therapeutic approach of Gilenya® (fingolimod, Novartis), and has been shown in clinical trials to significantly reduce MS relapses.
  • According to a press release from Celgene, the FDA determined that the pharmacology sections in the application were not sufficient; pharmacology provides information on how a therapy acts within the body and how the body responds.
  • There is no information on how long this action might delay the review of ozanimod. Celgene announced its intention to seek immediate guidance, including requesting a meeting with the FDA to ascertain what additional information will be required.
Background: Ozanimod is a selective sphingosine 1-phosphate receptor modulator. It 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.
The results of two phase 3 trials of ozanimod in relapsing MS were presented at the 2017 ECTRIMS conference. Both trials suggested that ozanimod significantly reduced relapse rates compared to people on Avonex® (interferon beta-1a, Biogen) over two years and showed benefits on MRI-detected disease activity. Although there was no evidence that ozanimod slowed the progression of disability compared to those on Avonex, both groups had low rates of progression, making it difficult to see an effect.
Read More:
Read more about the FDA’s review process
Read more about medications the modify the disease course in MS
Avonex is a registered trademark of Biogen
Gilenya is a registered trademark of Novartis AG

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.