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.
Zeposia is also the first in this treatment class to allow relapsing MS patients to “initiate” its use without requiring a genetic test or a first-dose observation period, according to BMS.
CHMP’s positive opinion was based on data from the largest head-to-head clinical trials in relapsing MS, showing that ozanimod was superior to Avonex (an injectable formulation of interferon beta-1a by Biogen).
The global Phase 3 SUNBEAM (NCT02294058) and RADIANCE part B (NCT02047734) studies compared the safety and effectiveness of two doses of Zeposia capsules (0.5 mg and 1 mg), given daily, to that of weekly intramuscular injections of Avonex for up to two years in people with RRMS or active SPMS.
Results from each trial showed that both doses led to significantly greater reductions in annualized relapse rates — the number of relapses per year — and brain lesions in patients than those given Avonex.
Analysis of pooled data from both trials — covering 2,659 people treated over one to two years — highlighted that Zeposia lowered the annualized relapse rates by 48% through one year, and by 38% through year two, compared with Avonex.
Patients treated with Zeposia also showed a drop in the rate of relapses requiring steroid treatment or hospitalization, by 43% in the higher dose group and 26% in the lower dose group, compared with those given Avonex.
Pooled magnetic resonance imaging (MRI) data also highlighted that Zeposia led to a greater reduction in the number of active brain lesions and in total amount of lesion area, of both old and new lesions, than Avonex at one and two years.
The therapy was generally safe and well-tolerated. The most commonly reported adverse effects were upper respiratory infection, high levels of transaminase (a liver enzyme), orthostatic hypotension (blood pressure drop when standing or sitting), urinary tract infection, back pain, and high blood pressure.
Should the European Commission support CHMP’s opinion, health authorities in each EU member state will decide whether to bring Zeposia into their respective public health programs, where patients can access the treatment at low or no cost.
Ozanimod is also being evaluated as a potential treatment for ulcerative colitis and Crohn’s disease.
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