Biogen and partner Eisai are stepping up to collect more data on their Alzheimer’s disease drug Aduhelm, and they have now announced plans for 6,000 patients Real world researchIt needs to be clear that this study is not a confirmatory clinical trial required as a condition for accelerated approval of a drug.
This observational study will enroll patients in approximately 200 locations in the United States over four years. These patients will receive up to five years of follow-up to understand the prescribed drugs and their effects in routine clinical practice. The main goal of the study is to characterize and evaluate the long-term changes in cognition, function, and neuropsychiatric status of patients treated with Aduhelm. Biogen and Eisai announced plans for this observational study at the Alzheimer’s Association International Conference, which will be held in Denver this week in a virtual manner.
Aduhelm is an antibody drug designed to reduce the level of beta amyloid, a protein that accumulates in the brains of patients with Alzheimer’s disease.Intravenous drugs obtained According to the agency’s accelerated approval path, the regulator nodded in JuneThe decision ignored the vote of the FDA advisory panel against the proposed approval on the grounds that the drug failed in a key study.
The consequences of Adhuelm’s approval have sparked controversy in many respects. Although the drug’s clinical trials failed, many in the scientific community expressed regret over the approval. Others criticized the process, and it was reported that certain FDA officials discussed the drug’s application when the drug was under regulatory review. Proponents of the drug criticized Aduhelm’s annual price of $56,000.The initial approval, whose wording implied a broader range of indications than those tested in clinical trials, led Cambridge, Massachusetts-based Biogen to seek a Update the label of Aduhelm to clarify that the drug should be used in patients with Alzheimer’s disease with mild cognitive impairment or mild dementia It is not widely used in patients with Alzheimer’s disease.
Accelerated approval is based on a faster decision with less evidence than is usually required in a drug application. As a condition of such approval, the company needs to provide additional post-marketing clinical data to confirm the drug’s benefits to patients. Biogen said that the confirmatory study is still being designed.
Biogen stated that it aims to increase the representation of minority groups in real-world research, setting the goal to have black and Latino patients account for at least 16% of the 6,000 clinical trial participants. There are three clinical projects planned to generate new data about Aduhelm. In addition to real-world studies and confirmatory studies, Biogen is also conducting an ongoing Phase 3b re-dosing study. The clinical trial is recruiting qualified patients who have previously participated in the Aduhelm clinical trial.
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