The Committee for Medicinal Products for Human Use (CHMP) has recommended Zeposia (ozanimod) oral capsules to be approved in the European Union (EU) to treat adults with active relapsing-remitting multiple sclerosis (RRMS).
“This positive CHMP opinion reinforces that Zeposia has the potential to become an important treatment option for patients with relapsing-remitting MS with active disease. There remains a need for effective and safe therapies that impact both the relapses and brain lesions that are characteristic of this disease,” Samit Hirawat, MD, chief medical officer of Bristol Myers Squibb (BMS), which will market Zeposia, said in a press release.
“We look forward to the European Commission’s decision and the potential to bring Zeposia to patients in the EU,” Hirawat added.
If approved, Europe will follow Zeposia’s recent approval in the U.S. (as 0.92 mg capsules) to treat adults with all relapsing forms of MS, including RRMS, active secondary progressive MS (SPMS), and clinically isolated syndrome.
An sphingosine-1-phosphate (S1P) receptor modulator, Zeposia is a small molecule that selectively blocks S1P receptor subtypes S1PR1 and S1PR5 present at the surface of lymphocytes — white blood cells involved in the inflammatory attacks against nerve cell fibers (a hallmark of MS).
By blocking the activity of these receptors, Zeposia prevents lymphocytes from leaving the lymph nodes, entering the circulation, and reaching the brain and spinal cord, where they can promote further inflammation and nerve cell damage.
Two other oral S1PR modulators — Gilenya (fingolimod) and Mayzent (siponimod) by Novartis — are already approved for relapsing forms of MS. However, Zeposia — developed by Celgene, a subsidiary of BMS — is thought to have a better safety profile than Gilenya due to its higher selectivity to S1P receptors.
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