Express delivery of more than 70% of patients without recurrence within 4 years, and the new drug for multiple sclerosis has a positive long-term effect

▎Bristol-Myers Squibb (BMS), editor of WuXi AppTec's content team, announced today that the S1P receptor modulator Zeposia (ozanimod) has achieved positive results in a phase 3 clinical extension trial for the treatment of patients with relapsing multiple sclerosis (MS)
.

The patient's annual recurrence rate (ARR) was 0.
103, and more than 70% of patients had no recurrence at the 48th month
.

Bristol-Myers Squibb has already submitted a marketing application for this new drug in China in July this year
.

Multiple sclerosis is a chronic inflammatory demyelinating disease of the central nervous system
.

Its important feature is that the immune cells in the human body attack the myelin sheath that protects the nerve, resulting in damage and shedding of the myelin sheath
.

Continuous damage to the myelin sheath will cause the electrical signals transmitted by the nerve to fail to propagate normally
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As a result, patients may experience symptoms such as decreased vision, diplopia, limb sensory disorders, limb movement disorders, ataxia, bladder or rectal dysfunction and other symptoms
.

Zeposia is a second-generation oral selective S1P receptor modulator
.

The lymphocytes flowing in the blood circulation and the lymphatic circulatory system will continue to enter and exit the lymph nodes, and S1P is a signal that regulates the migration of lymphocytes out of the lymph nodes
.

If the function of the S1P receptor is affected, lymphocytes will stay in the lymph nodes because they cannot recognize the signals that migrate out of the lymph nodes
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This therefore reduces the number of inflammatory lymphocytes that migrate to the central nervous system and attack the myelin sheath, reducing the damage to the myelin sheath
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Zeposia was approved by the US FDA in March 2020 to treat relapsing multiple sclerosis
.

This open-label extended clinical trial included 2494 patients.
At 36 months and 48 months of treatment, the proportions of patients without disease recurrence were 75% and 71%, respectively
.

In 13.
9% of patients, the disability progression was observed for 3 months, and in 11.
4% of the patients, the disability progression was observed for 6 months
.

In terms of safety, Zeposia showed safety features consistent with previous results
.

At a median treatment time of 46.
8 months, 85.
9% of patients had any treatment-related adverse events (TEAE), 11.
9% of patients had serious TEAEs, and 3% of patients stopped treatment because of TEAEs
.

The most common adverse events were nasopharyngitis (19.
6%), headache (15.
8%), upper respiratory tract infection (11.
1%) and lymphopenia (10.
3%)
.

"Early effective intervention can significantly affect the patient's long-term physical and cognitive outcomes
.

" said Dr.
Bruce Cree of the Multiple Sclerosis Center at the University of California, San Francisco.
"These data more clearly describe the long-term efficacy and safety characteristics of Zeposia, and again emphasize It has the potential to be used as a treatment for early relapsing multiple sclerosis
.

"Reference: [1] Bristol Myers Squibb Announces Up to Five Years of Data from Long-Term DAYBREAK Study Reinforcing Efficacy and Safety Profile of Zeposia (ozanimod) in Patients with Relapsing Forms of Multiple Sclerosis.
Retrieved October 13, 2021, from https ://investors.
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