Regulatory Affairs

FDA rejects Celgene’s NDA for relapsing multiple sclerosis drug ozanimod

PBR Staff Writer Published 28 February 2018

The US Food and Drug Administration (FDA) has rejected Celgene’s new drug application (NDA) for relapsing multiple sclerosis drug, ozanimod.

Ozanimod is being developed for the treatment of patients with relapsing forms of multiple sclerosis.

Ozanimod is an oral and selective sphingosine 1-phosphate 1 (S1PR1) and 5 (S1PR5) receptor modulator in development for immune-inflammatory indications such as ulcerative colitis and Crohn's disease, in addition to multiple sclerosis.

Selective binding with S1PR1 is thought to suppress a specific sub set of activated lymphocytes from migrating to sites of inflammation, which could reduce circulating T and B lymphocytes that result in anti-inflammatory activity.

After completion of preliminary review, the FDA concluded that the nonclinical and clinical pharmacology segments in the NDA were insufficient to allow a complete review.

Celgene said it intends to seek immediate guidance, including requesting a Type A meeting with the FDA, to find out what additional information will be needed to resubmit the NDA.

Celgene global regulatory affairs head and chief medical officer Jay Backstrom said: "We remain confident in ozanimod's clinical profile demonstrated in the pivotal program in relapsing forms of multiple sclerosis.

"We will work with the FDA to expeditiously address all outstanding items and bring this important medicine to patients."

In October 2017, Celgene presented results from the phase III Radiance Part B trial, which assessed the efficacy and safety of ozanimod against first-line treatment Avonex (interferon beta-1a or IFN) in patients with relapsing multiple sclerosis

The study assessed two doses, including 1mg and 0.5mg, of oral ozanimod compared with IFN in 1,320 patients with relapsing multiple sclerosis in 21 countries treated for two years.

According to the company, a significant reduction in new or enlarging T2 lesions was demonstrated in the study for ozanimod 1mg and 0.5mg.