PRINCETON -
ZEPOSIA is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity selectively to S1P subtypes 1 (S1P1) and 5 (S1P5). The CHMP recommendation will now be reviewed by the
'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,' said
The CHMP adopted the positive opinion based on data from the randomized, active-controlled Phase 3 SUNBEAM and RADIANCE Part B clinical trials, which enrolled more than 2,600 patients across 150 sites in more than 20 countries. The
About SUNBEAM
SUNBEAM is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ZEPOSIA (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular
The primary endpoint of the trial was annualized relapse rates (ARR) during the treatment period. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 12 months, number of gadolinium-enhanced brain MRI lesions at month 12 and percent change from baseline in whole brain volume at month 12. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.
An analysis of the time to onset of three-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.
About RADIANCE
RADIANCE Part B is a pivotal, phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trial evaluating the efficacy, safety and tolerability of two doses of oral ZEPOSIA (0.92 mg and 0.46 mg, equivalent to 1 mg and 0.5 mg ozanimod HCI, respectively) against weekly intramuscular
The primary endpoint of the trial was ARR over 24 months. The secondary MRI endpoints included the number of new or enlarging hyperintense T2-weighted brain MRI lesions over 24 months, number of gadolinium-enhanced brain MRI lesions at month 24 and percent change from baseline in whole brain volume at month 24. Cortical grey and thalamic volume changes were also prospectively assessed versus active comparator.
An analysis of the time to onset of three-month confirmed disability progression was pre-specified using pooled data from both the SUNBEAM and RADIANCE Part B phase 3 trials.
About Multiple Sclerosis
Multiple sclerosis (MS) is a disease in which the immune system attacks the protective myelin sheath that covers the nerves. The myelin damage disrupts communication between the brain and the rest of the body. Ultimately, the nerves themselves may deteriorate - a process that's currently irreversible. MS affects 700,000 people in
Relapsing remitting MS (RRMS) is characterized by clearly defined attacks of worsening neurologic function. These attacks - often called relapses, flare-ups or exacerbations - are followed by partial or complete recovery periods (remissions), during which symptoms improve partially or completely with no apparent progression of disease. RRMS is the most common disease course at the time of diagnosis. Approximately 85 percent of patients are initially diagnosed with RRMS, compared with 10-15 percent with progressive forms of the disease.
About ZEPOSIA (ozanimod)
ZEPOSIA (ozanimod) is an oral, sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. ZEPOSIA blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. The mechanism by which ZEPOSIA exerts therapeutic effects in multiple sclerosis is unknown but may involve the reduction of lymphocyte migration into the central nervous system.
ZEPOSIA is also in development for additional immune-inflammatory indications, including ulcerative colitis and Crohn's disease.
About
Celgene and
Cautionary Statement Regarding Forward-Looking Statements
This press release contains 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that the CHMP opinion is not binding on the
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