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Find Clinical Drug Pipeline Developments & Deals for ADUHELM
Under the termination, Neurimmune regained global rights to aducanumab, a recombinant human antibody developed to deplete brain amyloid, for the treatment and prevention of Alzheimer’s disease.
The company withdrew its application following interactions with EMA’s Committee for Medicinal Products for Human Use indicating that data provided thus far would not be sufficient to support a positive opinion on marketing authorization of aducanumab by EMA.
The confirmatory ENVISION trial is a requirement based on FDA’s accelerated approval of ADUHELM® (aducanumab-avwa), a monoclonal antibody directed against amyloid beta, 100 mg/mL injection for intravenous use in early Alzheimer’s disease.
The accelerated approval of ADUHELM, a monoclonal antibody has been granted based on data from clinical trials showing effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit.
Data from the long-term extension study showed that ADUHELM (aducanumab-avwa) significantly reduced amyloid beta plaque levels out to Week 132. The data also showed that ADUHELM continued to decrease plasma p-tau181 levels at 128 weeks.
The collaboration between both companies has resulted in the approval of ADUHELM in the U.S. as the first treatment to address a defining pathology of Alzheimer’s disease, which is a significant step into a new chapter of Alzheimer’s therapy.
ADUHELM® (aducanumab-avwa) injection 100 mg/mL for intravenous use, is a monoclonal antibody that reduces amyloid-beta plaque and plasma p-tau181 is indicated for the treatment of Alzheimer’s disease.
The accelerated approval of ADUHELM has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.
ADUHELM is indicated for the treatment of Alzheimer’s disease. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
ADUHELM is a monoclonal antibody directed against amyloid beta. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease.
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