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Biogen has been criticized for the controversial approval of its new Alzheimer's disease drug Aduhelm (for related reports, please click on the "Alzheimer" label at the beginning of the article).
Recently, Biogen submitted data on another biomarker and An analysis by the company showed that the biomarker is related to the slowing of disease progression
.
In two Phase 3 trials that were announced by Biogen at the Clinical Trials of Alzheimer's Disease (CTAD) meeting in support of FDA approval, at the FDA-approved dose, Aduhelm significantly reduced phosphorylated tau(p- tau) The blood level of protein
.
When the FDA approved Aduhelm in June, the data supporting the approval included data on the drug's ability to reduce amyloid plaques in the brain
More importantly, Biogen's p-tau data correlated a greater reduction in problematic proteins with a reduction in cognitive and functional decline in the four clinical outcome measures
.
But whether this correlation is strong enough may still be controversial
Alzheimer's disease is characterized by a toxic accumulation of amyloid plates and tau tangles in the brain
.
Bojian Chief Medical Officer Maha Radhakrishnan explained in an interview before the data was published that one theory is that the aggregation of amyloid will increase the plasma level of soluble p-tau protein, which then leads to the aggregation of tau protein, which is followed by cognition.
Radhakrishnan said that new data shows that removing amyloid aggregation with Aduhelm can reduce the level of soluble p-tau protein, thereby slowing down the accumulation of tau protein quality, thereby slowing down the decline in clinical cognition
.
Specifically, in the Phase 3 EMERGE trial, the p-tau protein named p-tau181 by Aduhelm decreased by 13%, while the level of patients using placebo increased by 8%
Although Aduhelm has been shown to have the ability to reduce protein aggregates, its performance in improving the symptoms of Alzheimer's disease is still unclear, which is why the drug is strongly opposed by doctors
.
Regarding the more important results of Alzheimer's disease symptoms, Radhakrishnan introduced the "strong correlation" between the decrease of plasma p-tau and the reduction of disease progression among the four clinical outcome indicators of cognition and function
.
The four scores are the Clinical Dementia Rating Scale-Total Score, Simple Mental State Examination, Alzheimer's Disease Assessment Scale-Cognitive Subscale and Alzheimer's for Mild Cognitive Impairment (MCI) Disease Cooperative Research/Activity of Daily Living Scale
The correlation values of the four markers seen in Bojian’s trial were only between positive or negative 0.
11 to 0.
21 in the two trials
.
In statistics, the closer the value is to 1 or -1, the stronger the association
In addition to the two Phase 3 trials, Biogen also provided some baseline data for patients participating in the single-arm 3b trial called EMBARK
.
The trial includes patients who have used Aduhelm in previous clinical trials and are re-administering them and following them for two years to evaluate the long-term safety and effectiveness of the drug
EMBARK showed that despite the treatment gap compared with placebo, the reduction in amyloid plaques observed in previous trials was largely maintained in the FDA-approved Aduhelm administration group
.
More importantly, compared with placebo, Aduhelm's clinical function still declines slowly in value
While critics questioned Aduhelm’s benefit-risk profile, the FDA’s adverse event reporting system reported a death case related to the drug: A 75-year-old woman in Canada was diagnosed with brain swelling (imaging related to amyloid).
Abnormal) after death
.
This is a side effect of Aduhlem treatment
.
Since the death case came from outside the United States and the drug has not yet been approved in Canada, Royal Bank of Canada Capital Markets analyst Brian Abrahams speculates that the patient is undergoing treatment through the EMBARK trial
.
Radhakrishnan declined to comment on whether the case came from EMBARK
.
She said that Bojian is working with treating doctors and regulatory agencies to better understand the case
.
