Decision approves controversial alzheimer’s drug in the usa

Decision in the USA Controversial Alzheimer's drug approvedFor the first time in almost 20 years, the USA has approved a new drug to treat Alzheimer's disease. However, the remedy is controversial, because some experts believe that the effectiveness is not proven. Nevertheless, the U.S. Food and Drug Administration (FDA) gave the green light for the drug Aduhelm and its active ingredient aducanumab. It is the first novel treatment for the neurodegenerative disease to be approved since 2003, the FDA said.

The drug, developed by U.S. biotechnology company Biogen, is intended to be given as a monthly infusion to patients with early-stage Alzheimer's disease and stop mental decline. The drug, marketed as Aduhelm, is the first ever to target the underlying presence of certain proteins in the brain called beta-amyloid plaques, explained Patrizia Cavazzoni of the FDA.

FDA: benefits outweigh risks

Admission was granted on an expedited basis. This is used when the FDA considers a drug to be useful in the application, but there are still uncertainties. "As is often the case when interpreting scientific data, the expert community put forward different perspectives", Cavazzoni commented. An independent expert panel appointed by the FDA had come out against the approval in November. In 2019, two clinical trials testing aducanumab had been halted due to lack of prospect for success.

"We are very aware of the attention around this admission", the FDA has now said. It was concluded that the benefits outweighed the risks. The active ingredient would now continue to be closely monitored, and the manufacturer would also have to conduct further studies. "If the drug doesn't work as intended, we can take steps to take it off the market again", the U.S. Food and Drug Administration.

Decision in the us approves controversial alzheimer's drug

Between hope and doubt – the FDA approved Aduhelm as an Alzheimer's drug. If the efficacy is not confirmed, it will be withdrawn from the market. Image: AP

Treat the cause instead of the symptoms

The drug had shown a decline in mental decline in patients in one clinical trial, but not in a second trial. In both studies, however, the drug reduced the formation of the protein beta-amyloid in the brains of Alzheimer's patients. One of the theories of Alzheimer's is that the disease is caused by an excessive accumulation of these proteins in the brains of aging people. Giving antibodies to the protein could be a way to restore mental abilities in patients.

"On behalf of those affected by Alzheimer's and all other dementias, we celebrate today's historic decision", explained the US Alzheimer's Association. Neurologist John Hardy of University College in London, on the other hand, said the drug has only "marginal benefit" and could help only a few selected patients. All drugs approved to date treat symptoms associated with Alzheimer's, but not the underlying cause.

Approximately 50 million people affected worldwide

Biogen did not initially name a price for the drug. According to experts, the treatment could lead to 30.000 to 50.000 dollars. Alzheimer's is estimated to affect about 50 million people worldwide, usually starting around age 65. The disease destroys after. After brain tie. Affected individuals lose cognitive abilities, become forgetful and are often disoriented. Also extreme mood swings. Communication problems are associated with the disease.

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