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On December 21, the official website of the State Drug Administration announced that the anti-CD20 monoclonal antibody ofatumumab injection (ofatumumab) submitted by Novartis had been approved for the treatment of adult relapsing multiple sclerosis (RMS), including clinical isolated syndrome, relapsing-remitting multiple sclerosis and active secondary progressive multiple sclerosis
.
Image source: Screenshot of NMPA official website
Ofatumumab is a new fully human monoclonal antibody targeting CD20.
It can remove B cells from the blood circulation by binding to CD20 on the surface of B cells
.
The drug was first approved by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in 2009 and is administered by intravenous infusion
It is worth mentioning that ofatumumab was approved by the U.
S.
FDA in August this year to treat adult patients with relapsing multiple sclerosis.
The product is administered by subcutaneous injection once a month, and patients can self at home.
Administration
.
It is worth noting that ofatumumab's use in the treatment of multiple sclerosis is different from the previously approved dosing regimen and route of administration for the treatment of CLL
.
It is reported that the drug regimen specially designed by the research team for multiple sclerosis indications plays a key role in the treatment results
In the phase 3 clinical trials of ASCLEPIOS I and II, the researchers compared the safety and effectiveness of ofatumumab and the control group in the treatment of adult patients with RMS.
The primary endpoint of the study was the annual recurrence rate (ARR) as of the end of the study.
.
The results showed that compared with the control group therapy, ofatumumab significantly reduced patients’ ARR and confirmed aggravation of disability, and reduced activity or new brain damage
In addition, Novartis also determined the bioequivalence of the Sensoready automatic injection pen for subcutaneous injection of orfatuzumab in RMS patients in a phase 2 study
.
In 2020, Novartis submitted an imported new drug marketing application of ofatumumab in China and was included in the priority review.
It is suitable for the treatment of adult relapsing multiple sclerosis, including clinical isolated syndrome, relapsing/remitting multiple sclerosis And active secondary progressive multiple sclerosis
.
Image source: Screenshot of CDE official website
Multiple sclerosis (MS) is a chronic disease of the central nervous system that destroys the normal function of the brain, optic nerve and spinal cord through inflammation and tissue damage
.
The progression of MS can lead to increased loss of physical function and cognitive function
