FDA approved the first new cure for Alzheimer's disease in almost 20 years

FDA approved the first new cure for Alzheimer's disease in almost 20 years

The drug is one of the few significant achievements in the fight against Alzheimer's disease, but it is also controversial.

"For the first time in two decades, we have a new approved treatment for Alzheimer's," said Dr. Babak Tussi, who led multi-centre clinical trials at the Cleveland Clinic, but critics say that there is little evidence that this drug is useful and potential side effects cause concern.

The story of aducanumabe, a drug developed by Biogen, is full of contradictions. The first of its kind is directed at the root of Alzheimer's disease, not just at its symptoms. It functions as an antibodies targeted at amyloid, a protein that forms an anomalous accumulations in the brain of people suffering from Alzheimer's disease, which can cause the destruction and destruction of the brain cells of the patient.

Aduelm can reduce the amyloid level in the brain and slow down the cognitive function in patients, especially in the early stages of the disease, as well as in combination with healthy lifestyles. It's far from perfect, but it's still a big leap from where we left off just 10 years ago.

But not everyone is convinced of that. As part of the FDA authorization process, any drug has to prove its effectiveness in two similar clinical trials.

It was only after a follow-up analysis by Biogen and FDA, which analysed the additional data that were missing at the time of the end of the test, that the results were found to be quite promising; these new data included a larger number of patients taking higher doses of the drug and found that Aduhelm was really effective in reducing beta-amyloids in the brain, and many believed that Alzheimer's characteristic.

What further complicates the situation is that 40 per cent of patients who have received an approved dose of Aduelm have developed a temporary painful swelling of the brain, and 17 per cent of patients who have received an approved dose of Aduhelm have developed a temporary cerebral swelling.

The U.S. Food and Drug Administration itself acknowledged that Biogen needed to provide more evidence by directing the drug manufacturer to conduct a study after the drug had been approved to examine its benefits. If it did not provide such evidence of clinical benefit, FDA approval could be withdrawn.

But some fear that even in this case the FDA decision may allow more drugs to obtain approval with insufficient evidence. Even though there is a desperate need for treatment, it does not justify approval of drugs that have not fully proven their value, and some researchers fear that this creates a dangerous precedent. The FDA explained that Aduelm has been granted the status of Fast Track, aimed at accelerating the development and revision of drugs designed to treat serious conditions when initial data show that they can meet unmet medical needs.

This is not the only interesting discovery in Alzheimer's, but the pharmaceutical giant Eli Lilly also presented promising results on his medication for Alzheimer's disease earlier this year and is already working on a basic study of phase 3.