U.S health regulators have approved the first Alzheimer’s drug in almost a decade despite some concerns about effectiveness.
The drug, which will be sold as Aduhelm though its molecular name is Aducanumab, targets the underlying cause of Alzheimer’s rather than its symptoms.
Developed by Biogen, the drug comes after billions of dollars of investments into Alzheimer’s drug research.
The Food and Drug Administration (FDA) said there was “substantial evidence that aducanumab reduces amyloid beta plaques in the brain” and that this “is reasonably likely to predict important benefits to patients.”
The drug’s approval provides hope to millions of people around the globe dealing with Alzheimer’s, a progressive degenerative disease that slowly causes loss of memory and decreases people’s ability to care for themselves.
However, doubts about the drug still remain.
Questions have been raised about the effectiveness of Aduhelm as the impact that it can have on some patients may be limited, particularly for those with more advanced cases of the disease.
There are also questions among the scientific community as it is yet to be answered whether the drug creates a reduction or reversal in cognitive decline among patients, the Independent reports.
Additionally, the treatment will come at an expense with health insurer Cigna estimating that some patients eligible for treatment may face $10,000 or more in annual out-of-pocket costs, The Wall Street Journal claims.
While Biogen estimated it would charge around $56,000 a year, per patient.
“We come to this historic moment with thanks for the inspiring contributions of thousands of Alzheimer’s patients and caregivers who participated in our clinical trials, for the pioneering work of scientists and researchers inside and outside Biogen, and for the relentless dedication of our employees globally,” said Biogen Chief Executive Michel Vounatsos in a statement.
“The approval of ADUHELM lays the foundation for creating a new treatment paradigm around Alzheimer’s disease, but what’s needed is far bigger than what any one medicine or any single company can achieve on its own. Today’s milestone is a major step forward in changing Alzheimer’s disease from a disease often perceived as an inevitable consequence of aging to a condition with a new treatment option.”
Aduhelm is the first Alzheimer’s drug to be approved since 2003.