Celgene re-files for US approval of ozanimod

26 March 2019

US biotech major Celgene (Nasdaq: CELG) has re-submitted a New Drug Application to the US Food and Drug Administration for ozanimod for the treatment of adults with relapsing forms of multiple sclerosis (RMS).

Last year the FDA issued a ‘refuse to file’ letter on the ozanimod NDA for this indication. Annual sales of the drug had been projected to reach as much as $3.46 billion by 2024.

Ozanimod is an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5), noted Celgene, currently the subject of a $74 billion takeover offer from Bristol-Myers Squibb (NYSE: BMY).

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