CHMP Backs Ozanimod (Zeposia) for Multiple Sclerosis

Megan Brooks

Disclosures

March 27, 2020

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of ozanimod (Zeposia, Celgene Europe BV) for adults with relapsing remitting multiple sclerosis (RRMS) with active disease as defined by clinical or imaging features.

Ozanimod is an oral once-daily immunomodulator that selectively targets sphingosine-1-phosphate 1 (S1P) and five receptors. It will be available as 0.23 mg and 0.46 mg capsules for dose escalation and 0.92 mg capsules for maintenance.

The US Food and Drug Administration approved ozanimod for relapsing forms of MS yesterday, although Celgene said it will delay launch of the drug because of the ongoing COVID-19 pandemic, as reported by Medscape Medical News.

In the phase 3 SUNBEAM and RADIANCE trials, ozanimod reduced clinical relapses and gadolinium-enhancing (GdE) lesions and new or enlarging T2 lesions in patients with relapsing MS.

In a statement, the EMA said it's not exactly clear how ozanimod exerts therapeutic effects in MS, but may involve the reduction of lymphocyte migration into the central nervous system.

The most common side effects are nasopharyngitis and lymphopenia; less common side effects are hypertension and increased liver enzyme level.

Ozanimod should be prescribed by physicians experienced in the treatment of MS, the EMA said.

Detailed recommendations for the use of ozanimod will be described in the summary of product characteristics, which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorization has been granted by the European Commission.

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