Celgene announced Tuesday that it has received a refusal-to-file letter from the FDA concerning the company's marketing application for ozanimod in the treatment of patients with relapsing forms of multiple sclerosis. The drugmaker explained that following a preliminary review, the FDA concluded that the nonclinical and clinical pharmacology sections in the submission were not sufficient to allow a complete review. Celgene chief medical officer Jay Backstrom commented "we will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients."
The drugmaker indicated that it will request immediate guidance to determine what additional information is needed for a resubmission of the treatment. In May last year, Celgene announced that the experimental therapy achieved the primary endpoint of the RADIANCE Phase III study in patients with relapsing multiple sclerosis. However, the company said at the time that in a pre-specified pooled analysis of data from the RADIANCE trial and the previously reported late-stage SUNBEAM study, ozanimod was not associated with a significant difference in the rate of disease progression versus Avonex.
FirstWord reports in this therapy area - KOL Insight Multiple Sclerosis: Find out how KOLs expect the market to evolve, which pipeline treatments are most promising, and which clinical trials will shape treatment decisions. Learn more.
Commenting on the latest news, Jefferies analyst Michael Yee suggested that it was "extremely unlikely that there is an inherent regulatory problem." The analyst added that it was "merely a delay and yet another short term problem that does not inspire Street confidence."
Analysts had previously forecast revenue of $263 million for ozanimod next year, with sales of about $3.5 billion by 2024. Celgene, which is also developing the therapy for the treatment of other immune-inflammatory conditions such as ulcerative colitis and Crohn's disease, gained rights to ozanimod via its $7.2-billion acquisition of Receptos in 2015.
For related analysis, read ViewPoints: Big questions about ozanimod raise bigger questions about Celgene.
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