After a long and painful trial, the U.S. Food and Drug Administration (FDA) approved a new Alzheimer’s drug, less than 20 years after the last approval. This is the monoclonal antibody Aducanumab (trade name Aduhelm), which is designed to directly target the beta amyloid plaques that accumulate in the patient’s brain.
This Alzheimer’s disease Is the main form dementia Worldwide, it is estimated that tens of millions of people suffer from this disease, 500mira Which is in Italy. This is about a Neurodegenerative diseases Does not exist yet concern, But only drug Can reduce-temporarily-I symptom Features, from Memory loss Difficult language And indirection. Alzheimer’s disease is a progressive and unstoppable Cognitive decline. The pathological trigger mechanism is not fully understood, but the “sticky” protein ( beta amyloid plaque with Your protein) In brain tissue, cause death Neurons Therefore neurodegenerative diseases. As pointed out, there is no drug that can effectively prevent or reverse the progression of Alzheimer’s, but now the U.S. Food and Drug Administration (FDA) Just approved A promising new treatment that can bring real benefits to millions of people with dementia.
The drug in question is Aducanumab, a monoclonal antibody-sold under the trade name Aduheim -It has a benign target that directly targets amyloid plaques that accumulate in the brain. Therefore, by reducing the concentration of these proteins, it aims to slow down the neurodegenerative process and improve cognitive performance.However, FDA approvals related to the accelerated approval process are not without confused electronic dispute, Due toincomplete data In the clinical studies provided by the manufacturer, the United States BiogenIn short, Aducanumab has been shown in trials to reduce the accumulation of beta-amyloid plaques in patients’ brains, but it is not clear whether this process can really ensure overall improvement in memory and other cognitive impairments.
I just want to say that in November, an advisory committee of the FDA stated that the results of Biogen’s study failed to prove that the symptoms of Alzheimer’s disease had improved, so Aducanumab would not be approved.This is just the last “hiccup” on the road, leading toFDA approvedFor example, in 2019, two clinical trials were terminated early because an interim analysis predicted that they might fail.Nevertheless, Biogen continued to conduct data analysis. In a subgroup of patients, the drug actually reduced the level of amyloid beta in brain tissue and highlighted some cognitive benefits, such as improved language skills electronic Mnemonic. The advisory committee that analyzed these data and data from other trials (one is late and the other is early) concluded that there are too many gaps in the approval of the drug, but FDA officials instead Considered valid The results of the Phase 3 study submitted by the company. Therefore, after the decision was postponed from March 7th to June 7th this year, the final decision was made to approve marketing. But there are reservations.
In fact, because the data is considered incomplete, the FDA has specifically requested Biogen to continue research follow up After the drug is dispensed, monitor the patients receiving treatment (based on Monthly infusion) Pass specific tests, such as magnetic resonance and cognitive tests.It should also be remembered that there is insufficient data for Aducanumab patients Serious form Alzheimer’s disease. Despite these limitations, Biogen’s monoclonal antibodies are still expected to bring significant benefits to patients after repeated failures of other drugs.It can be said that this is the first new drug since the FDA approved it for the treatment of a wide range of dementia in 2003 Memantina For oral use. “There has been quite a lot of public debate about whether to approve Aduhelm. As often encountered when interpreting scientific data, the expert community offers different perspectives,” he said in a statement. Press release Dr. Patrizia Cavazzoni, Director of the US FDA Center for Drug Evaluation-Research. “The agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweigh the risks of treatment,” the scientist concluded. All that remains is to wait for the results of marketing (no date has been set) and basic follow-up research.