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Today, TG
Therapeutics announced that the US FDA has approved its CD20 protein antibody Briumvi (ublituximab) for the treatment of recurrent multiple sclerosis (RMS).
This is also the 36th innovative drug
approved by the FDA this year.
Recurrent multiple sclerosis is a chronic central nervous system demyelinating disease that occurs when the immune system attacks the myelin sheath that protects nerves, and consists of relapsing-remitting multiple sclerosis (RRMS) as well as secondary progressive multiple sclerosis (SPMS).
The former is a common form of multiple sclerosis, characterized by repeated new/worsening symptoms alternating
with periods of recovery.
It is estimated that there are about 1 million people with multiple sclerosis in the United States, and about 2.
3 million people worldwide have been diagnosed with multiple sclerosis
.
Ublituximab is a sugar-engineered monoclonal antibody that targets unique epitopes
on CD20 antigens expressed by B cells.
When ublituximab binds to B cells, it can trigger a series of immune responses such as antibody-dependent cytotoxicity (ADCC) and complement-dependent cytotoxicity (CDC) to destroy B cells
.
These cells are thought to be key factors
in causing axon damage to myelin sheaths and nerve cells.
A unique feature of Ublituximab is that it bioengineered to remove certain naturally occurring sugar molecules from anti-CD20 antibodies, thereby significantly enhancing the efficacy of ublituximab to trigger ADCC, which can be achieved
at lower doses.
on CD20 antigens expressed by B cells.
A unique feature of Ublituximab is that it bioengineered to remove certain naturally occurring sugar molecules from anti-CD20 antibodies, thereby significantly enhancing the efficacy of ublituximab to trigger ADCC, which can be achieved
at lower doses.
The approval is based on two separate randomized, double-blind, active control trials of global, multicenter clinical Phase 3 (ULTIMATE I and ULTIMATE
II）
。 In this trial, a total of 1094 patients with RMS from 10 countries were enrolled
in both arms.
Patients in the Ublituximab group receive up to 4 hours on day 1 for 150
mg intravenous infusion, 450 mg of drug infusion for more than 1 hour on day 15, plus 450 mg for 1 hour every 6 months
mg drug infusion
.
Patients in the teriflunomide group were given oral lozenges
containing 14 mg of medicine once a day.
The primary endpoint of the trial was the annual recurrence rate (ARR)
of patients in the ublituximab group compared to the active control group over 96 weeks.
Data analysis showed that both groups of trials met the primary endpoint
.
At ULTIMATE
In trial I, patients in the ublituximab group (n=271) had an ARR of 0.
076 and a control group (n=274) of 0.
188 (p<0.
001), while in ULTIMATE
In the II trial, the ARR of patients in the ublituximab group (n=272) was 0.
091, and the control group (n=272) was 0.
178 (p=0.
002).
076 in the ublituximab group (n=271) and 0.
188 (p<0.
001) in the control group (n=274), while in ULTIMATE In the II trial, the ARR of patients in the ublituximab group (n=272) was 0.
091, and the control group (n=272) was 0.
178 (p=0.
002).
Full data published in August this year showed that mixed analysis of safety and resistance in both groups of trials showed that 89.
2% of patients (486/545) experienced at least one adverse reaction
.
The proportions of patients with grade 3 or above adverse events in the ublituximab group and the control group were 21.
3% (n=116) and 14.
1% (n=77),
respectively.
The most common adverse reaction associated with ublituximab was infusion-related reactions
.
Mr.
Michael Weiss, President and Chief Executive Officer of TG Therapeutics
Michael Weiss, President and Chief Executive Officer of TG Therapeutics
Michael President, CEO of TG Therapeutics, Inc
In his press release, Mr.
Weiss noted that today's FDA approval marks an exciting day
.
At the same time, he also mentioned that he believes that the drug can bring unique value
to patients and doctors.
Congratulations on the launch of this innovative therapy and look forward to more patients getting rid of the pain of multiple sclerosis as soon as possible!
