New drugs made from living cells given and injected reduce cerebral palsy, giving hope to patients.
Health officials in the United States on Monday approved a new treatment for Alzheimer’s disease – the first in nearly 20 years – that would give hope to 6.2 million Americans and many others around the world aged 65 years with leukemia.
On Monday, the Food and Drug Administration (FDA) announced it had approved the use of aducanumab for Alzheimer’s disease.
It is the only drug approved by U.S. authorities to address the underlying cause of the disease, the amount of fatty acids in the brain. Clinical trials of this new drug, developed by Biogen Inc, showed a decrease in symptoms, thus contributing to a decrease in mood.
However, the FDA’s approval of the drug is controversial due to warnings from independent experts that the drug does not work. The FDA wants Biogen to undergo further clinical trials to determine the best possible results.
Representative groups representing Alzheimer’s patients and their families say any new treatment – even one of the few – should be approved.
Biogen did not immediately disclose the price, though researchers say the drug could be between $ 30,000 and $ 50,000 per year of treatment.
A preliminary study by the nonprofit Institute for Clinical and Economic Review found that the drugs would have to pay $ 2,500 to $ 8,300 a year in order to be profitable based on the “small profits” claimed by industry research.
These new drugs are made from living cells that must be given through injection into a doctor’s office or hospital. The Alzheimer’s Association hailed the election as a popular process.
Breaking news: The FDA has approved Aducanumab, the first FDA-approved drug that has slowed the decline due to Alzheimer’s. On behalf of those affected by Alzheimer’s disease & all other dementia, we are celebrating an old concept today. pic.twitter.com/2oJIeMADog
– Alzheimer’s Association (@alzassociation) June 7, 2021
Researchers do not fully understand the underlying causes of Alzheimer’s disease but there is a strong consensus that the brain block against aducanumab is the only one.
A growing body of evidence indicates family history, education and difficulties, such as diabetes and heart disease, all of which can be involved.
“This is one of the challenges and I think all of these alternatives need to be explored and developed,” Dr Ronald Petersen, a Mayo Clinic medical specialist who consulted Biogen and drug makers told The Associated Press.
In November, the FDA outside the team of neurologists voted “no” to a number of questions as a review of another Biogen-based study showed that the drug was effective.
Biogen was suspended two studies of the drug in 2019 after the side effects of aducanumab, marketed by Biogen such as Aduhelm, will not achieve its goal of reducing Alzheimer’s mental and emotional decline.