The first new treatment for Alzheimer’s disease for nearly 20 years has been approved by the Food and Drug Administration (FDA) for use in USA. However, it has not yet been approved in UK.
The new drug, aducanumab (Aduhelm), is administered intravenously once a month and has been approved for all patients with Alzheimer’s disease. It is not a cure for the disease, but “is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline,” according to the manufacturer, Biogen.
The drug works by targeting amyloid beta plaques (toxic protein) on the brain, which are thought to destroy neurones and cause dementia.
Some scientists are sceptical about the benefits
In clinical trials, aducanumab reduced amyloid beta plaques by 59 to 71 percent at 18 months of treatment. However, some scientists are sceptical about the benefits of the new treatment.
An independent panel of experts reviewed the data from the trial and could not conclude that the treatment had significant benefit for patients.
There was no doubt of the drugs ability to remove the plaques on the brain, rather about whether removing the plaques has cognitive benefits. The FDA have therefore instructed Biogen to complete a large clinical trial to prove these benefits, otherwise it can withdraw its approval.
A "historic moment" in the field of Alzheimer’s disease
Despite this uncertainty, the approval of aducanumab has provided hope for millions of people with Alzheimer’s, as well as their family members and caregivers. Already, those involved in the clinical trials of the drug have spoken out about how the treatment has helped them feel less confused and more confident in their abilities.
Michel Vounatsos, Chief Executive Officer at Biogen, said: “This historic moment is the culmination of more than a decade of ground-breaking research in the complex field of Alzheimer’s disease. We believe this first-in-class medicine will transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come.
“We are grateful for the contributions of thousands of patients and caregivers who participated in our clinical trials, as well as for the dedication of our scientists and researchers. Together with the healthcare community, we are ready to bring this new medicine to patients and begin to address this growing global health crisis.”