A rendered image of a healthy neuron cell network. In patients with MS, the flow of information within the brain, and between the brain and body, becomes disrupted. (Stock image)

Ozanimod, a drug created at Scripps Research, gains European Commission approval for treatment of multiple sclerosis

The drug, marketed under the name Zeposia, received FDA approval in March.

June 01, 2020

LA JOLLA, CA—The European Commission has approved ozanimod, an immune-modulating therapy invented at Scripps Research, for the treatment of adults with relapsing forms of multiple sclerosis. Bristol Myers Squibb, which markets the drug under the trade name Zeposia, says the approval means that MS patients in the European Union will have a new first-line treatment option to address the disease’s hallmark relapses and brain lesions.

“The European Commission’s approval of ozanimod is a major win for Europe’s multiple sclerosis community, which has been in need of new, intelligent drug interventions to help patients control the progression of their disease,” says Hugh Rosen, MD, PhD, who invented ozanimod along with fellow Scripps Research professor Edward Roberts, PhD, and their laboratory colleague

The news comes less than two months after the therapy gained approval from the U.S. Food and Drug Administration for MS. The drug is also in advanced clinical development for adults and children with moderate-to-severe ulcerative colitis and Crohn’s disease. 

In patient studies supporting ozanimod's regulatory approvals, those who took the once-daily oral medicine experienced significantly less disease progression—including fewer relapses and preservation of the brain from atrophy—than those who received standard care, with very few side effects.

More than 700,000 people in Europe have MS, according to the European Multiple Sclerosis Platform, a nonprofit patient-driven organization. The vast majority of all MS patients are diagnosed with the relapsing forms of the disease that ozanimod is designed to treat.

In multiple sclerosis, the immune system mistakenly attacks myelin sheath, the protective layer that surrounds nerves in the brain. This disrupts the flow of information within the brain and between the brain and body, bringing about symptoms that can range from numbness and bladder issues to vision problems and muscle paralysis. 

Ozanimod works by acting on certain types of immune cells called lymphocytes that are centrally involved in the autoimmune attack on myelin sheath. It binds to receptors on the cells’ surface, keeping them from reaching the brain. As a result, the number of activated lymphocytes is decreased, diminishing the immune attack. Notably, ozanimod is the only approved drug for relapsing forms of MS that works in this way.  

The fundamental discoveries that led to ozanimod were reported by Rosen, Roberts and their Scripps Research colleagues in a series of papers from 2002 to 2008. In 2009, Scripps Research licensed ozanimod to biotechnology startup Receptos, which Celgene purchased in 2015 for $7.2 billion. Celgene was acquired by Bristol Myers Squibb in 2019.

Ozanimod is also being studied as a treatment for forms of inflammatory bowel disease, with late-stage clinical trials underway for ulcerative colitis and Crohn’s disease, for which it is a first-in-class treatment.

Ozanimod is the latest in a string of approved drugs to originate from Scripps Research’s laboratories, following on most recent approval of tafamidis for the rare but often fatal heart disease known ATTR-CM.

Scripps Research also invented drugs that have been brought to market to treat more than a dozen other high-need conditions including arthritis, lupus, respiratory distress syndrome, gastric cancer, metastatic non-small cell lung cancer, hemophilia, anthrax inhalation and neuroblastoma. Additional drugs are in development for more than 10 other conditions, ranging from osteoarthritis to Parkinson’s disease, with several in clinical trials.

Additional molecules developed by Rosen and Roberts at Scripps Research are currently in phase 2 clinical trials for major depressive disease and anxiety, and phase 1 studies for treatment of autism.

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