NEW FDA approved Alzheimer’s drug
Mindaugas from Aichom
The FDA has approved aducanumab - a novel drug for Alzheimer's disease, developed by a company Biogen. There are many discussions going on whether this approval was advantageous or had more negative sides to it. Why did FDA rush the approval for aducanumab?
The FDA has approved aducanumab - a novel drug for Alzheimer's disease, developed by a company Biogen.
There are many discussions going on whether this approval was advantageous or had more negative sides to it. Why did FDA rush the approval for aducanumab?
According to Biogen's data submitted, its clinical efficacy is questionable, as only one (#1) study out of two, showed benefits in cognition, and the other (#2) did not show any efficacy results for the treatment group. Only later, analysts at Biogen used the study (#2) to pick just a selected group of participants in the study, who had received the highest dose, and managed to show some clinical benefits.
Aducanumab was showed to reduce the concentration of amyloid-beta plaques among the study participants, this being a key factor for approving the drug (not slowing the cognitive decline). Aducanumab is the latest anti-amyloid antibody, while beta-amyloid is yet only weakly correlated with symptoms of Alzheimer's disease.
The FDA gave Biogen 9 years (from 2021) to conduct another study (phase IV) and submit new results to prove that the reduction of amyloid plaques in the brain results in clinical improvement for patients.
Some people in the scientific community call this action a "statistically manipulated drug", however, some agree that this approval also opens a previously closed market for substances in treating Alzheimer's disease.
Several amyloid reducing drugs have previously failed clinical trials, meaning that now new substances developed could be compared to the currently approved aducanumab and get approved, if better efficacy is discovered.
It is important to notice that scientifically, plaque deposition is a hallmark of the progression of Alzheimer's disease, however, there is no evidence supporting the fact that some decrease in plaque improves cognition in patients with Alzheimer's disease.
Biogen CEO Michel Vounatsos shared that the price for the treatment is planned to be $56,000 per year. People argue that it should cost as low as $2,500 per year for it to be considered cost-effective, yet research & development in the pharmaceutical industry is very costly, therefore, the listed price.
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