Saying that the benefits outweighed the risks, the Food and Drug Administration approved Biogen’s aducanumab on Monday. (BIIB) – Get report long-awaited drug for Alzheimer’s disease.
Shares of the Cambridge, Massachusetts company rose slightly to $ 286.43 on the latest check. The drugmaker’s shares have risen almost 17% so far this year.
The approval is for aducanumab, which will be marketed under the name “Aduhelm”. The decision makes the drug the first new treatment for Alzheimer’s disease in nearly two decades.
Biogen is partnering on the drug with Eisai from Japan.
“This approval is significant in many ways. Aduhelm is the first novel therapy approved for Alzheimer’s disease since 2003,” the FDA said in a statement. “Perhaps most significantly, Aduhelm is the first treatment to target the underlying pathophysiology of Alzheimer’s disease, the presence of beta amyloid plaques in the brain.”
The FDA said Aduhelm’s clinical trials “were the first to show that a reduction in these plaques, a hallmark finding in the brains of Alzheimer’s patients, is expected to lead to a reduction in the clinical decline of this devastating form of disease. dementia”. ”
The agency said it ultimately decided to use the Expedited Approval pathway, which is “intended to provide earlier access to potentially valuable therapies for critically ill patients where there is an unmet need and where there is an expectation of clinical benefit despite some residual uncertainty. “. with respect to that benefit. “
“By determining that the application met the Expedited Approval requirements, the Agency concluded that the benefits of Aduhelm for patients with Alzheimer’s disease outweighed the risks of the therapy,” the FDA said.
In January, analysts reacted positively to the FDA’s decision to extend the review period for aducanumab for three months.
In November, FDA scientific advisers recommended rejection of the drug.
The FDA’s Central and Peripheral Nervous System Drugs Advisory Committee voted 8 to 1 against recommending approval of Biogen’s aducanumab treatment, while two members cast “undecided” votes.
The agency is not required to follow the advice of its advisers, but generally follows the recommendations of its underlying advisory panels.
Alzheimer’s disease represents the sixth most prevalent cause of death in the US Biogen has estimated that around 1.5 million Americans would be eligible for treatment with aducanumab
Other companies have also been working on treatments for Alzheimer’s disease.
Annovis Bio (ANVS) – Get report Last month saw its shares take off after the clinical-stage drug platform company reported progress on a study involving a candidate for treating Alzheimer’s and Parkinson’s disease.
Eli lilly (LLY) – Get report said in March that donanemab, an investigational antibody, showed a 32% reduction in a composite measure of cognition and daily function in trial patients suffering from early symptomatic Alzheimer’s disease after phase 2 trials.
Cassava Sciences (SAVA) – Get report It said in February that it was planning a phase 3 clinical trial for its Alzheimer’s disease treatment candidate, simufilam.
Alzheimer’s disease is the most common cause of dementia. There are more than 50 million people around the world living with dementia, a number that is expected to increase to 150 million by 2050.
The worldwide cost of dementia is $ 818 billion, according to Alzheimer’s Disease International.