Celgene files for EU approval of ozanimod in relapsing-remitting MS, with US re-submission on track

Celgene on Monday announced the filing of a marketing application in Europe seeking approval of the oral, sphingosine 1-phosphate receptor modulator ozanimod for the treatment of relapsing-remitting multiple sclerosis. Celgene also said it remains on track to re-submit the agent for clearance in the US after the FDA issued a refuse-to-file letter in response to the company's application last year. 

Celgene's submission of the drug in Europe was backed by safety and efficacy data from the SUNBEAM and RADIANCE Part B trials. In the late-stage SUNBEAM trial, the results of which were reported in 2017, ozanimod was associated with significant improvements in annualised relapse rates versus Biogen's Avonex (interferon beta-1a).   

Celgene gained rights to ozanimod via its $7.2-billion takeover of Receptos in 2015. Celgene, which had blamed Receptos for issues related to the US submission, had previously expressed plans to re-submit the treatment to the FDA by the first quarter of this year.  

The news comes after Celgene reached a deal earlier this year to be purchased by Bristol-Myers Squibb for $74 billion, with ozanimod being mentioned at the time as being one of the "six expected near-term product launches" by the combined company. A number of investors, including Bristol-Myers Squibb's largest shareholder Wellington Management, have questioned the deal, while the drugmaker has reportedly met with investors in recent weeks to gain support for the transaction (for related analysis, see ViewPoints: Bristol-Myers Squibb and Celgene's best laid plans start to unravel). 

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