What is Aducanumab – The FDA-approved drug consists of a monoclonal antibody therapy that can be injected intravenously in patients with moderate Alzheimer’s disease. Aducanumab binds to molecules present in amyloid plaques (whose accumulation in the brain is associated with the disease, ed), thus reducing the rush of the disease and allowing people to continue doing daily activities such as cleaning the house and shopping.
A controversial drug – The decision by the US authorities, however, has effectively ignored warnings from independent consultants that Aducanumab has not been shown to help slow the disease. The drug is the only drug that US regulators say can likely cure the underlying disease rather than manage symptoms such as anxiety and insomnia.
The new study – Scientists’ doubts prompted Biogen to discontinue testing in October 2020. A new, larger-scale study, however, showed that the drug was effective when administered at higher doses. The decision, which could impact millions of American seniors and their families, is likely to spark disagreements between doctors, researchers and patient groups.
The crux of effectiveness – The new drug didn’t reverse the mental decline, it just slowed it down, according to recent research. The drug is given by infusion every four weeks. The FDA requested the manufacturer to conduct a new analysis to confirm the drug’s benefits for patients. If the study fails to prove its effectiveness, the FDA could withdraw the drug from the market, although this is a practice the agency rarely adopts.
The unknown price – Biogen did not immediately disclose the price, although analysts estimated the drug could cost between $ 30,000 and $ 50,000 for one year of treatment. A preliminary analysis by a group found that the drug would need a price of between $ 2,500 and $ 8,300 per year to get good value for the results. The Institute for Clinical and Economic Review added that “any price is too high” if the drug’s benefit is not confirmed in follow-up studies.