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US FDA and EMA approved Celgene’s ozanimod review application for treating Relapsing MS

The United States Food and Drug Application has approved the review of the new drug application of Celgene’s ozanimod. The review application was also approved by the European Medicines Agency. The drug is indicated for treating relapsing-remitting multiple sclerosis in Europe whereas it is approved for relapsing forms of multiple sclerosis in the United States.


Ozanimod was an oral-dosage sphingosine 1-phosphate (S1P) receptor modulator. The action date in the United States is March 25, 2020, whereas EMA decision is expected in the first half of 2020.


The safety and efficacy of the product are assessed using two trials.

SUNBEAM:

Phase 3 trial evaluating the safety, efficacy, and tolerability of two doses (0.92 mg and 0.46 mg) involving 1,346 people.

Primary endpoint annualized relapse rates (ARR) during the treatment period.

RADIANCE:

Phase 3 trial evaluating the safety, efficacy, and tolerability. Ozanimod was compared with interferon beta-1a over a period of 24 hours.

The primary endpoint was ARR. The study 1,320 people across 21 countries.

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cindywedwards822
11 juin 2019

I was diagnosed with Multiple Sclerosis (MS) in October 2012, at the age of 44. I woke up one morning with numbness in my lower back and legs, I couldn't feel my feet touching the floor. I saw my doctor and had an MRI to see if I had a disc problem, it was negative and she told me she feared MS. I was sent to a neurologist, had two more MRIs, and was told that night that I have four lesions on my spine MS. I tried every shots available but nothing worked. In 2015, my neurologist and I decided to go with natural treatment and was introduced to Organic Herbal Clinic natural organic MS Herbal formula, i had…

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