Clinical trials that can prove the effectiveness of Biogen’s Alzheimer’s disease drug Aduhelm are scheduled to begin in May and will take about four years-about half of the initial estimate. The study will recruit patients globally and aims to include placebo controls.
Thursday announcement The clinical trial plan of Biogen in Cambridge, Massachusetts is in FDA accelerates approval of AduhelmFor diseases with few treatment options, such as Alzheimer’s, this approach allows drugs to enter the market faster. The FDA makes these rapid decisions based on the surrogate endpoint, which is a signal that the drug may be effective in clinical trials.
Aduhelm is an antibody drug designed to break down amyloid plaques in the brain. The results of Aduhelm’s clinical trials are unclear, but the accelerated approval is based on alternatives that reduce amyloid plaques in the brain. Confirming that this reduction actually benefits Alzheimer’s patients requires post-marketing research, which is a condition for all accelerated approval decisions.
The Aduhelm confirmatory study will recruit more than 1,300 patients in the early stages of Alzheimer’s disease. Biogen and partner Eisai stated that they hope to submit the final clinical trial protocol to the FDA in March, and then begin patient screening in May.
When Aduhelm first received accelerated approval from the FDA, The agency has set an eight-year timeline for confirmatory researchThe clinical trials of drugs for neurological diseases are very large, and because it takes time to recruit patients and evaluate the effects of drugs in these patients, they may last for several years. The main goal of Aduhelm’s post-marketing study is to evaluate patients 18 months after the start of treatment. Biogen said that based on the enrollment rate previously studied by Aduhelm, the primary school completion date is expected to be about four years after the start of the study. A long-term extension study will collect additional treatment data for up to 48 months.
As the review of Biogen and Aduhelm became more and more stringent, the clinical trial plan was also introduced. The company puts a price tag of $56,000 per year on the drug, and many insurance companies are reluctant to cover this amount. In October, the company stated in its third-quarter financial performance report that Aduhelm’s sales totaled only $300,000-far below expectations.Last month, the European Medicines Agency Committee gave a Negative trend voting On Aduhelm, the vote heralded that the agency’s official opinion on the drug’s marketing authorization application was not optimistic.
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