FDA grants accelerated approval for first Alzheimer’s disease treatment
Biogen’s groundbreaking research in Alzheimer’s disease looks to transform the treatment of people living with Alzheimer’s disease and spark continuous innovation in the years to come
Add bookmark
Biogen and Eisai, have received approval from the US Food and Drug Administration (FDA) for their Alzheimer’s drug, aducanumab, making it the first Alzheimer’s medication to be approved by US regulators.
The treatment has been surrounded by some controversy with some scientists opposing its approval, saying it does not work, The Irish Times reported.
The FDA has acknowledged the contentious nature of their decision, however, based on the data from the clinical trials of aducanumab, Biogen and Eisai released a statement confirming their confidence in the drug for reducing amyloid beta plaques, a sticky deposit of protein found in the brain of patients with early stages of Alzheimer's.
The companies have also said continued approval for aducanumab as a treatment for Alzheimer’s disease may be contingent upon verification of clinical benefit in confirmatory trials.
Dr Ronald Petersen, an Alzheimer's disease expert at the Mayo Clinic, told RTÉ: “This is good news for patients with Alzheimer's disease. We have not had a disease-modifying therapy approved ever.
"This is not a cure, however, it is hoped that this will slow the progression of the disease," Petersen continued.
Michel Vounatsos, Chief Executive Officer at Biogen, said: “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.”
Become a member of Pharma IQ to receive regular insights and analysis on the latest industry trends.
